Identity
- Trade Name
- Puregraft 50 EUDAMED
- Device Name
- Puregraft 50 System EUDAMEDPuregraft 50 EUDAMED
- Model / Reference
- 50/Pure EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850034511122 EUDAMED
- Basic UDI-DI
- 085003451150/PUREAA EUDAMEDB-00850034511122 EUDAMED
- Unit of Use DI
- 00850034511108 EUDAMED
- EMDN Code
- Z12040214 LIPOSUCTION SYSTEMS EUDAMEDA99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDSpain 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 50 by Bimini Health Tech — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 085003451150/PUREAA | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 085003451150/PUREAA | 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 (2)
- EUDAMED b46d9143-8ddf-40a7-82de-1c2f81e46d33 61 fields · synced Jul 14, 2026
- EUDAMED c5b98713-3227-459e-9d9f-4ae39b09cfa7 61 fields · synced May 19, 2026