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dermagel plus PI micro
EUDAMEDClass IIa (EU MDR)
Ref RC50067055_2937Ref RC50067085_2937Ref RC50067090_2937Ref RC50066055_2937Ref RC50067060_2937Ref RC50067080_2937Ref RC50066070_2937Ref RC50066060_2937Ref RC50066065_2937
Identity
- Trade Name
- dermagel plus PI micro EUDAMEDdermagel plus PI EUDAMED
- Device Name
- Powder free synthetic polyisoprene surgical gloves EUDAMED
- Model / Reference
- RC50067055_2937 EUDAMEDRC50067085_2937 EUDAMEDRC50067090_2937 EUDAMEDRC50066055_2937 EUDAMEDRC50067060_2937 EUDAMEDRC50067080_2937 EUDAMEDRC50066070_2937 EUDAMEDRC50066060_2937 EUDAMEDRC50066065_2937 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06931923801266 EUDAMED06931923801327 EUDAMED06931923801334 EUDAMED06931923800535 EUDAMED06931923801273 EUDAMED06931923801310 EUDAMED06931923800566 EUDAMED06931923800542 EUDAMED06931923800559 EUDAMED
- Basic UDI-DI
- 697178707SGPIU3 EUDAMED
- EMDN Code
- T01010203 POLYISOPREN 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
No
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 PI micro 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 | 697178707SGPIU3 | 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 (9)
- EUDAMED 489bce88-3601-4202-a6ed-5a386ec8ac6f 61 fields · synced Oct 6, 2026
- EUDAMED 6aec4e7e-f93d-4c70-a760-aa8fa5c1f762 61 fields · synced May 16, 2026
- EUDAMED 1b7b8600-f151-43b8-a50f-946f746c0c4e 61 fields · synced May 16, 2026
- EUDAMED dd0123e7-a8c5-4d13-89e1-757712e2f4d0 61 fields · synced May 18, 2026
- EUDAMED c77623c4-49c9-4f51-b2a6-c73a4114b533 61 fields · synced May 18, 2026
- EUDAMED c31fab44-70bb-4392-a6f6-a332cb3ba82a 61 fields · synced May 18, 2026
- EUDAMED ff4fa9ec-5f87-4409-ba69-3ed6d81f7e28 61 fields · synced May 18, 2026
- EUDAMED b8601f8a-4f03-49c8-b60f-41a980c32a82 61 fields · synced May 18, 2026
- EUDAMED 7f1816a5-d40b-486e-aea2-595a70ebeeaf 61 fields · synced May 18, 2026