Identity
- Trade Name
- Puregraft 850 EUDAMED
- Device Name
- Puregraft 850 EUDAMED
- Model / Reference
- 850/PURE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850034511160 EUDAMED
- Basic UDI-DI
- B-00850034511160 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 850 by Bimini Health Tech — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00850034511160 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00850034511160 | 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 511b55f6-b447-40ef-b1a6-9bac44aa4da7 61 fields · synced Jun 18, 2026