Identity
- Trade Name
- dermagel basic EUDAMED
- Device Name
- Powder free natural rubber latex surgical gloves EUDAMED
- Model / Reference
- RC10082065_2937 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931923802966 EUDAMED
- Basic UDI-DI
- 697178707SGNRUF EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
dermagel basic by Guilin Hbm Health Protections, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697178707SGNRUF | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guilin HBM Health Protections, Inc.
- EUDAMED SRN
- CN-MF-000033439
- Authorised Representative
- Continental Medical B.V. NL-AR-000022261
Sources (1)
- EUDAMED 8eb2ed86-f18d-45d2-ada9-3c356c683e7b 61 fields · synced Jun 18, 2026