Identity
- Trade Name
- FreeDerm EUDAMEDFDA UDI
- Generic Name
- Patient medical adhesive remover FDA UDI
- Device Name
- FreeDerm Adhesive Remover EUDAMEDFreeDerm Adhesive Remover 6 ml Wipe FDA UDI
- Model / Reference
- 90037 EUDAMEDFDA UDI
- Description
- FreeDerm Adhesive Remover 6 ml Wipe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00653599000649 EUDAMEDFDA UDI
- Basic UDI-DI
- 0653599FDSF EUDAMED
- Direct Marketing DI
- 00653599000649 EUDAMED
- FDA Product Code
- KOX FDA UDI
- EMDN Code
- M9003 SOLUTIONS FOR ADHESIVE TAPE REMOVAL EUDAMED
- GMDN Term
- Patient medical adhesive remover FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4730 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FreeDerm by Argentum Medical, Llc — Class I — 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 | 0653599FDSF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Argentum Medical LLC
- EUDAMED SRN
- US-MF-000003391
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 195f9404-cb62-4899-a612-07243e4efed8 61 fields · synced Oct 6, 2026
- FDA UDI fb478a72-7be6-45f6-93f5-f713ee6ac2d9 35 fields · synced May 30, 2026