Identity
- Trade Name
- Puregraft 850 EUDAMED
- Device Name
- Puregraft 850 System EUDAMED
- Model / Reference
- 850/Pure EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850034511207 EUDAMED
- Basic UDI-DI
- 0850034511850/PUREC4 EUDAMED
- EMDN Code
- Z12040214 LIPOSUCTION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Puregraft 850 by Bimini Health Tech — Class IIa — 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 | 0850034511850/PUREC4 | 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 5b6386c3-e0fc-4de5-8bb2-43916794cdae 61 fields · synced Jun 18, 2026