Identity
- Trade Name
- Spike Adapters EUDAMED
- Device Name
- S-FFP12 EUDAMED
- Model / Reference
- S-FFP12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20816203021902 EUDAMED
- Basic UDI-DI
- B-20816203021902 EUDAMED
- EMDN Code
- B0180 BLOOD BAGS AND KITS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spike Adapters by OriGen Biomedical, Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20816203021902 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OriGen Biomedical Inc.
- EUDAMED SRN
- US-MF-000018098
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 6684656e-d04e-475a-9f94-9a0d1c9dd41e 61 fields · synced May 29, 2026