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dermagel plus orthopedic
EUDAMEDClass IIa (EU MDR)
Ref RC10063085_2937Ref RC10063075_2937Ref RC10063070_2937Ref RC10063060_2937Ref RC10063080_2937
Identity
- Trade Name
- dermagel plus orthopedic EUDAMED
- Device Name
- Powder free natural rubber latex surgical gloves EUDAMED
- Model / Reference
- RC10063085_2937 EUDAMEDRC10063075_2937 EUDAMEDRC10063070_2937 EUDAMEDRC10063060_2937 EUDAMEDRC10063080_2937 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931923800351 EUDAMED06931923800337 EUDAMED06931923800320 EUDAMED06931923800306 EUDAMED06931923800344 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 orthopedic 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 b84b8455-1237-428c-99ef-59208f27ae0e 61 fields · synced Oct 6, 2026
- EUDAMED cec9fa95-3d0d-44b9-af27-d51f54fb95c2 61 fields · synced May 16, 2026
- EUDAMED 20f80dc7-cb75-4f43-a2d2-42727b5fe10e 61 fields · synced May 17, 2026
- EUDAMED 2d2c3305-37e6-4984-ad77-198e4886b07f 61 fields · synced May 18, 2026
- EUDAMED 49f0668c-d7c6-47ef-889b-ca7aa6224f21 61 fields · synced May 19, 2026