Identity
- Trade Name
- Puregraft 250 EUDAMED
- Device Name
- Puregraft 250 System EUDAMED
- Model / Reference
- 250/Pure EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850034511184 EUDAMED
- Basic UDI-DI
- 0850034511250/PURE8J 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 250 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 | 0850034511250/PURE8J | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0850034511250/PURE8J | 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 bc2c9b0a-3885-4e9d-bccd-20427cbb9761 61 fields · synced Jul 15, 2026