Identity
- Trade Name
- Streck Cell-Free DNA BCT CE EUDAMED
- Device Name
- Cell-Free DNA BCT CE EUDAMED
- Model / Reference
- 218996 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 40844509002251 EUDAMED
- Basic UDI-DI
- 08445090CFBCTCEBX EUDAMED
- Unit of Use DI
- 00844509002253 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Streck Cell-Free DNA BCT CE by Streck — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08445090CFBCTCEBX | Class A | Active |
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Manufacturer
- Manufacturer
- Streck
- EUDAMED SRN
- US-MF-000013009
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED c906e4ad-f8f6-4d61-9efc-94a42beff5b9 61 fields · synced Jun 18, 2026