Identity
- Trade Name
- dermagel plus dual EUDAMED
- Device Name
- Powder free natural rubber latex surgical gloves EUDAMED
- Model / Reference
- RC10064065_2937 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931923800399 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 plus dual 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 |
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Manufacturer
- Manufacturer
- Guilin HBM Health Protections, Inc.
- EUDAMED SRN
- CN-MF-000033439
- Authorised Representative
- Continental Medical B.V. NL-AR-000022261
Sources (1)
- EUDAMED 0c967a44-7d90-4f00-8500-0db8de5ff8bf 61 fields · synced Jun 19, 2026