Identity
- Trade Name
- FPU (Fat Processing Unit) EUDAMEDFPU(Fat Processing Unit) FDA UDI
- Generic Name
- Autologous adipose tissue noninvasive processing set FDA UDI
- Device Name
- Fat Processing Unit (TP-101N) EUDAMED
- Model / Reference
- TP-101N EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800052308886 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800052308886 EUDAMED
- FDA Product Code
- MUU FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Autologous adipose tissue noninvasive processing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Market of Registration
- Hungary 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
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
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
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
FPU (Fat Processing Unit) by Medikan Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800052308886 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Medikan Co., Ltd.
- EUDAMED SRN
- KR-MF-000037547
- Authorised Representative
- CALMED INVEST Kft. HU-AR-000006313
Sources (2)
- EUDAMED c2bc8e1d-01d8-4fe4-b353-af29a1e6190b 61 fields · synced Jul 12, 2026
- FDA UDI 7046e679-cb8e-4736-9e4e-acd101aab71d 33 fields · synced May 30, 2026