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dermagel plus coated
EUDAMEDClass IIa (EU MDR)
Ref RC10061070_2937Ref RC10061080_2937Ref RC10061085_2937Ref RC10061060_2937
Identity
- Trade Name
- dermagel plus coated EUDAMED
- Device Name
- Powder free natural rubber latex surgical gloves EUDAMED
- Model / Reference
- RC10061070_2937 EUDAMEDRC10061080_2937 EUDAMEDRC10061085_2937 EUDAMEDRC10061060_2937 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931923800160 EUDAMED06931923800184 EUDAMED06931923800191 EUDAMED06931923800146 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 coated 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 (4)
- EUDAMED 92517abd-7a23-44a2-8d19-12cb5fa3e694 61 fields · synced Oct 6, 2026
- EUDAMED a3cba7e3-9f2f-409c-9e40-0d2d7e7de761 61 fields · synced May 18, 2026
- EUDAMED aafa7057-35f7-41b0-b1d5-b8691a569fe4 61 fields · synced May 19, 2026
- EUDAMED f9e4d34d-2024-4926-a7a7-bac77ba1e26b 61 fields · synced May 19, 2026