Updated 25 October 2026
IVD distributors in Romania: 0 independent, 14 licensed firms
Romania has 14 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 in vitro diagnostics, laboratory diagnostics and diagnostic reagent distributors in Romania: the Index groups analysers, reagents, rapid tests and laboratory consumables in one segment.
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Include manufacturers, their own sales entities and regulatory representatives (14)
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.
- 1DELTAROM SRLGiurgiu0 lines0 registrationsSize score 46 of 100
- 2SC MEDICAMED MARKET SRLBucuresti0 lines0 registrationsSize score 45 of 100
- 3Sanimed International Impex S.A.Calugareni0 lines0 registrationsSize score 44 of 100
- 4VitroBioChem SRLBucuresti0 lines0 registrationsSize score 25 of 100
- 5Themis Pathology SRLBucuresti0 lines2 registrationsSize score 27 of 100
- 6Tody Laboratories Med SRLBucuresti0 lines0 registrationsSize score 34 of 100
- 7SC SPD STAR SRLCaseiu0 lines0 registrationsSize score 28 of 100
- 8V-Veil Up Production SRLCalinesti0 lines0 registrationsSize score 26 of 100
- 90 lines0 registrationsSize score 25 of 100
- 10S.C. CAMP MEDICA DISTRIBUTION SRLBucuresti0 lines0 registrationsSize score 24 of 100
- 11PHARMASAVE SRLJudet Ilfov0 lines0 registrationsSize score 23 of 100
- 12Tody Laboratories Int. SRLBucharest0 lines0 registrationsSize score 20 of 100
- 13S.C BIOGEN VET S.R.LBacau0 lines0 registrationsSize score 19 of 100
- 14SC MEDDO SRLSebes0 lines0 registrationsSize score 22 of 100
In-vitro diagnostics covers analysers, reagents, rapid tests and laboratory consumables across chemistry, haematology, microbiology, immunology and genetics. IVD has its own regulation in most markets, and the EU regulates it under IVDR rather than MDR. Laboratory distributors usually differ from device distributors, even inside the same company.
The Bastion Hale Distributor Index lists 14 establishments in Romania whose registry records include in-vitro diagnostics: 0 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 4 manufacturers' own import or sales entities, 0 regulatory representatives, and 10 manufacturers or exporters, out of 877 medical device establishments in Romania overall. The records come from EUDAMED and MHRA UK, last seen on 23 October 2026.
Entry decision: in-vitro diagnostics in Romania
CE marked: go now, rank 23 of 124. FDA cleared: not now, rank 90 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 IVD means unknown, not none.
FDA cleared, shipping from the US
Not now blocked for this maker today
Rank 90 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 IVD 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 in-vitro diagnostics, 421 in Romania overall.
Makers registered here: 4 makers' own import or sales entities and 10 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: in-vitro diagnostics. 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 in-vitro diagnostics: about USD 110m to 170m 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 7.9m to 24m a year. SOM, what a new maker with one good distributor could win a year after about three years, is about USD 110k to 670k (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 | 4 | 29% | Named as importer: EUDAMED importer. |
| Manufacturer | 14 | 100% | Registered as a manufacturer with an address in this market: EUDAMED manufacturer; MHRA registered manufacturer. |
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 IVD distributors in Romania
How many IVD distributors are licensed in Romania?
The Index counts 14 establishments in Romania with in-vitro diagnostics 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 and MHRA UK and was last refreshed on 25 October 2026.
Who distributes laboratory reagents and analysers in Romania?
The Index counts laboratory reagents and analysers with the other in-vitro diagnostics. None of the 14 firms in Romania with in-vitro diagnostics 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 an in-vitro diagnostics 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 an IVD 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 an IVD 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 in-vitro diagnostics 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 in-vitro diagnostics 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 in-vitro diagnostics market in Romania?
Health spending in Romania was USD 20.0bn in 2023 (World Bank). Bastion Hale estimates the in-vitro diagnostics market at about USD 110m to 170m 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
In-vitro diagnostics in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 14 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- 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.