Identity
- Trade Name
- Puregraft 50 Single Pack EUDAMED
- Device Name
- 50/PURE Single Pack EUDAMED
- Model / Reference
- 50/PURE-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850034511115 EUDAMED
- Basic UDI-DI
- B-00850034511115 EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Puregraft 50 Single Pack by Bimini Health Tech — 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-00850034511115 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bimini Health Tech
- EUDAMED SRN
- US-MF-000008649
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 36140db3-b0f6-4b0e-88f0-5a82411039f1 61 fields · synced Jul 25, 2026