Updated 25 October 2026
Medical consumables distributors in Romania: 0 independent, 40 licensed firms
Romania has 40 licensed establishments in the Index and no independent distributor yet. EUDAMED does not list distributors, so the Index cannot see them here yet. The real number is higher than zero.
This page covers medical supplies, medical disposables and wound care distributors in Romania: the Index groups syringes, gloves, wound care, infusion, sterilisation and infection control products in one segment.
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Include manufacturers, their own sales entities and regulatory representatives (40)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
- 10 lines1 registrationSize score 31 of 100
- 2Coramed Medizinische Produkte SRLBucuresti0 lines0 registrationsSize score 40 of 100
- 3STERISACO SRLConstanta0 lines0 registrationsSize score 32 of 100
- 4Deluxe Medicrafts srlBucuresti0 lines0 registrationsSize score 25 of 100
- 5Noscares SRLBucharest0 lines0 registrationsSize score 25 of 100
- 6BANDTEX GRUP S.R.L.Saucesti0 lines0 registrationsSize score 23 of 100
- 70 lines0 registrationsSize score 20 of 100
- 8MAGNUM s.r.l.Satu Mare0 lines0 registrationsSize score 18 of 100
- 9Global Treat srlGalati0 lines0 registrationsSize score 24 of 100
- 10Textile MedicaleArad0 lines1 registrationSize score 26 of 100
- 110 lines1 registrationSize score 24 of 100
- 12MILLENNIUM UTILITY SRLMarmatiei0 lines1 registrationSize score 18 of 100
- 13LAROPHARMMagurele Ilfov0 lines1 registrationSize score 16 of 100
- 14Tex Acces MCV S.R.L.Bragadiru0 lines0 registrationsSize score 45 of 100
- 15EUROCOSMETIC s.r.l.Alesd0 lines0 registrationsSize score 34 of 100
- 16Alison Hayes (Romania) SRLUrziceni0 lines0 registrationsSize score 30 of 100
- 17INPOINT MEDICAREChiajna0 lines0 registrationsSize score 30 of 100
- 18SC SPD STAR SRLCaseiu0 lines0 registrationsSize score 28 of 100
- 19PRODCONFARM SRLPitesti0 lines0 registrationsSize score 28 of 100
- 20V-Veil Up Production SRLCalinesti0 lines0 registrationsSize score 26 of 100
General hospital and consumables covers syringes, gloves, wound care, infusion, sterilisation and infection control. It is a high-volume, low-margin business where wholesalers and group purchasing dominate. Local manufacturing is common, so many establishments here are domestic producers rather than importers.
The Bastion Hale Distributor Index lists 40 establishments in Romania whose registry records include general hospital and consumables: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 9 manufacturers' own import or sales entities, 0 regulatory representatives, and 31 manufacturers or exporters, out of 877 medical device establishments in Romania overall. The records come from EUDAMED, US FDA (openFDA) and MHRA UK, last seen on 23 October 2026.
Entry decision: general hospital and consumables in Romania
CE marked: go now, rank 23 of 124. FDA cleared: not now, rank 88 of 124. Show the full entry analysis
For a typical maker, from public data and the free Market Finder. Your own clearance, device class and current markets change the answer. The verdicts, best first: go now (route, channel and market size all work), go next (open, with one thing to solve first), build the case (two things to solve, or a full local registration in a large market), not now (blocked for this maker today).
CE marked, shipping from the EU
Go now the registration route, the sales channel and the market size all work
Rank 23 of 124 markets for this maker.
Your CE marking is the market authorisation; foreign makers sell through distributors here; health spending of USD 20.0bn (2023, World Bank); distributor numbers not countable here because EUDAMED does not list distributors.
Medium confidence: EUDAMED does not list distributors, so a zero for hospital consumables means unknown, not none.
FDA cleared, shipping from the US
Not now blocked for this maker today
Rank 88 of 124 markets for this maker.
Held back: CE marking needed first; FDA clearance alone is not accepted here.
Medium confidence: EUDAMED does not list distributors, so a zero for hospital consumables means unknown, not none.
Registration route
With CE marking: Your CE marking is the market authorisation. High confidence.
With FDA clearance: CE marking needed first; FDA clearance alone is not accepted here. High confidence.
No local holder is needed for a maker based inside this regulatory area. Who holds the registration
CE marking under the MDR is the market authorisation; no national approval. A non-EU maker needs an EU authorised representative.
Timeline and fees are not shown: no official source we cite gives them for this market yet. Confirm with a regulatory specialist before you plan a launch date. Sources: Regulation (EU) 2017/745 on medical devices (MDR), EUR-Lex.
Sales channel
Distributor-led: Foreign makers sell through distributors here. Local agents, distributors and JV partners are the usual route, though not legally required.
US Commercial Service country guide, published 10 June 2026.
Independent distributors in the Index: 0 for general hospital and consumables, 421 in Romania overall.
Makers registered here: 9 makers' own import or sales entities and 31 manufacturers.
Landed cost
Landed cost from the EU: no duty or import tax collected at the border (same customs area).
Landed cost from the US: about 21% collected at the border, under 1% real after credits (high confidence, from published tariff and tax rates). No duty, import VAT or GST about 21%.
Tariff basket: general hospital and consumables. Cash is collected at clearance. Real cost is what stays after a registered distributor recovers VAT and charges. Sources: World Bank WITS TRAINS tariff API, reporter 918, MFN applied, HS6, Your Europe: VAT rates applied in EU member countries (last checked 13/07/2026).
Market size
Health spending: USD 20.0bn in 2023, USD 1,051 per person (World Bank).
Whole market (TAM) for general hospital and consumables: about USD 140m to 210m a year (estimate, low confidence). TAM is all yearly spending on these devices in the market.
For one product line sold through distributors: SAM, the part of that spending distributors can reach, is about USD 9.9m to 30m a year. SOM, what a new maker with one good distributor could win a year after about three years, is about USD 140k to 830k (estimates). The free Market Finder sizes your own product range.
Broad scope, as in MedTech Europe figures: devices, diagnostics and consumables at manufacturer prices. Narrower published figures are lower.
How we estimate. At manufacturer prices.
Next step
The finder ranks every market for your own device, clearance and current markets. The CSV lists 872 establishments, the 418 independent distributors first. Company records only. 5 rows are not in the CSV and stay on their profile pages, for example names of a person or records whose only source is the Health Canada licence list.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 8 | 20% | Named as importer: EUDAMED importer. |
| Authorised representative | 1 | 2% | Represents a foreign manufacturer towards the regulator: EU authorised representative in EUDAMED. |
| Manufacturer | 40 | 100% | Registered as a manufacturer with an address in this market: EUDAMED manufacturer; US FDA registered manufacturer; MHRA registered manufacturer. |
| Exporter | 1 | 2% | Registered as an exporter of devices: US FDA registration as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Romania
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers register separately in EUDAMED. Distributors do not register there, which is why the Index lists few EU distributors. Neither owns the CE file, so EU channel changes are easier than elsewhere.
Who holds medical device registrations in Romania: the list
This is the general rule, not legal advice. The registration clause in the first distributor contract decides who controls the market later. The Next 10 Markets report covers who holds the registration in each of your ten markets.
Next steps
Questions about medical consumables distributors in Romania
How many medical consumables distributors are licensed in Romania?
The Index counts 40 establishments in Romania with general hospital and consumables in their registry record, of which 0 are independent distributors (a channel role and no manufacturing of their own). EUDAMED does not list distributors, so the Index cannot see them here yet. The real number is higher than zero. The number comes from EUDAMED, US FDA (openFDA) and MHRA UK and was last refreshed on 25 October 2026.
Who distributes medical supplies and disposables in Romania?
The Index counts medical supplies and disposables with the other hospital consumables. None of the 40 firms in Romania with hospital consumables on record is an independent distributor in the registries yet. EUDAMED does not list distributors, so the Index cannot see them here yet. The real number is higher than zero.
Who can hold a general hospital and consumables device registration in Romania?
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers register separately in EUDAMED. Distributors do not register there, which is why the Index lists few EU distributors. Neither owns the CE file, so EU channel changes are easier than elsewhere.
How do I find a medical consumables distributor in Romania?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Romania to see the names, free, no sign-up. For a ranked shortlist for your device, see the Next 10 Markets report.
What does the Distributor Index count as a medical consumables distributor in Romania?
A company that appears in a public regulatory registry with an address in Romania and whose linked device listings fall in the general hospital and consumables segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
How are CE-marked and FDA-cleared general hospital and consumables devices registered in Romania?
With CE marking: your CE marking is the market authorisation. With FDA clearance: CE marking needed first; FDA clearance alone is not accepted here. No local holder is needed for a maker based inside this regulatory area. CE marking under the MDR is the market authorisation; no national approval. A non-EU maker needs an EU authorised representative. Confirm with a regulatory specialist before you plan a launch date.
How big is the general hospital and consumables market in Romania?
Health spending in Romania was USD 20.0bn in 2023 (World Bank). Bastion Hale estimates the general hospital and consumables market at about USD 140m to 210m a year at manufacturer prices. This is a model estimate with low confidence: health spending times the device share of health spending times the segment's share of world medical technology spending. The methodology page shows every input and source.
Other segments in Romania
General hospital and consumables in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 36 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 4 establishments, last seen 22 October 2026. US government work, public domain.
- UK MHRA Public Access Registration Database (PARD): 1 establishment, last seen 23 October 2026. Public register.
Index build 25 October 2026. Each establishment is counted once per country after resolving names across sources. Company records only, as the registries publish them.
Registry data. Bastion Hale does not vouch for any establishment.