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dermagel plus dual
EUDAMEDClass IIa (EU MDR)
Ref RC10064080_2937Ref RC10064070_2937Ref RC10064075_2937Ref RC10064060_2937Ref RC10064090_2937
Identity
- Trade Name
- dermagel plus dual EUDAMED
- Device Name
- Powder free natural rubber latex surgical gloves EUDAMED
- Model / Reference
- RC10064080_2937 EUDAMEDRC10064070_2937 EUDAMEDRC10064075_2937 EUDAMEDRC10064060_2937 EUDAMEDRC10064090_2937 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931923800429 EUDAMED06931923800405 EUDAMED06931923800412 EUDAMED06931923800382 EUDAMED06931923800443 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 (5)
- EUDAMED 4d9a8092-2c5f-4a33-b271-70db75b0a54f 61 fields · synced Oct 6, 2026
- EUDAMED e01af500-0fc0-487c-851b-d0498a5197d1 61 fields · synced May 17, 2026
- EUDAMED a4b71b50-0245-44a7-a3aa-9e8f9b7ffda7 61 fields · synced May 18, 2026
- EUDAMED d9225262-63cf-406f-8f1b-afe5f31434c2 61 fields · synced May 18, 2026
- EUDAMED 53181028-b5a3-4843-9e7f-45c2ff41d672 61 fields · synced May 19, 2026