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Polyisoprene Powder Free Sugical Glove Premium
EUDAMEDClass IIa (EU MDR)
Ref MPIG55
Identity
- Trade Name
- Polyisoprene Powder Free Sugical Glove Premium EUDAMED
- Device Name
- Powder free synthetic polyisoprene surgical gloves EUDAMED
- Model / Reference
- MPIG55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971787073000 EUDAMED
- Basic UDI-DI
- 697178707SGPIU3 EUDAMED
- EMDN Code
- T01010203 POLYISOPREN SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Polyisoprene Powder Free Sugical Glove Premium 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 (1)
- EUDAMED cece9b6b-e14d-487d-acaa-9c478a0a421a 61 fields · synced Jun 18, 2026