Identity
- Trade Name
- Sterix supremesoft PP, size 6.5 EUDAMED
- Device Name
- Powdered Natural Rubber Latex Surgical Gloves EUDAMED
- Model / Reference
- 371GS165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933506092221 EUDAMED
- Basic UDI-DI
- 697178707SGNPUB EUDAMED
- EMDN Code
- T01010101 POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Sterix supremesoft PP, size 6.5 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 | 697178707SGNPUB | 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 c366301c-fdb0-49d9-8471-0d5ee0d66704 61 fields · synced Jun 18, 2026