Identity
- Trade Name
- BioPlus+ EUDAMEDFDA UDI
- Generic Name
- Synthetic-polymer liquid barrier dressing FDA UDI
- Device Name
- BioPlus+ Barrier Film Wipe EUDAMEDBioPlus+ Wipe FDA UDI
- Model / Reference
- 52301 EUDAMEDFDA UDI
- Description
- BioPlus+ Wipe FDA UDI
Identifiers
- Catalog Number
- 31150 FDA UDI
- Primary DI / UDI-DI
- 00653599000670 EUDAMEDFDA UDI
- Basic UDI-DI
- 0653599BPST EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
- GMDN Term
- Synthetic-polymer liquid barrier dressing FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 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
BioPlus+ 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 | 0653599BPST | 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 1804ddaf-b040-4356-85eb-04d0d979d4df 61 fields · synced Jul 10, 2026
- FDA UDI 3ec3b000-a3a0-40b6-a127-2e03b83c4886 36 fields · synced May 30, 2026