Identity
- Trade Name
- Dermapose EUDAMEDDermapose Access FDA UDI
- Generic Name
- Resective skin contouring/liposuction system depth guide FDA UDI
- Device Name
- Dermapose Refresh EUDAMEDA pre-assembled, sterile, single use system intended to assist the harvesting of autologous fat grafts from a patient for aesthetic body contouring. It creates a guided incision for cannula introduction at a controlled depth (10 mm) under the skin for the purpose of small volume adipose tissue harvest. FDA UDI
- Model / Reference
- REFRESH EUDAMEDACCESS FDA UDI
- Description
- A pre-assembled, sterile, single use system intended to assist the harvesting of autologous fat grafts from a patient for aesthetic body contouring. It creates a guided incision for cannula introduction at a controlled depth (10 mm) under the skin for the purpose of small volume adipose tissue harvest. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850034511306 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850034511REFRESH76 EUDAMED
- FDA Product Code
- QPB FDA UDI
- EMDN Code
- Z12040214 LIPOSUCTION SYSTEMS EUDAMED
- GMDN Term
- Resective skin contouring/liposuction system depth guide FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dermapose by Bimini Health Tech — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850034511REFRESH76 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 c79a0fbf-3f19-4bf2-ba0c-d520688cb607 61 fields · synced Jul 22, 2026
- FDA UDI 8852d940-0bfa-48e7-a07f-9c8acfdb71d9 33 fields · synced May 30, 2026