Identity
- Trade Name
- CertiLabel EUDAMED
- Model / Reference
- Certilabel EUDAMED60434365 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G197604343650 EUDAMED
- Basic UDI-DI
- ++G197CertiLabelAY EUDAMED
- EMDN Code
- B0180 BLOOD BAGS AND KITS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CertiLabel by BBS S.r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G197CertiLabelAY | Class I | Active |
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Manufacturer
- Manufacturer
- BBS S.r.l.
- EUDAMED SRN
- IT-MF-000007274
Sources (1)
- EUDAMED bc855e83-6428-432d-ae72-db252694c66e 61 fields · synced Jul 12, 2026