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Surgitex
EUDAMEDClass IIa (EU MDR)
Ref CodeT01010102NON-POWDERED LATEX SURGICAL GLOVESModel CLW-PF-7.5
Identity
- Trade Name
- SURGITEX EUDAMED
- Device Name
- NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
- Model / Reference
- CLW-PF-7.5 EUDAMEDCodeT01010102NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925634021006 EUDAMED
- Basic UDI-DI
- 69256340SLSGNWN EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa 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
Surgitex by Suzhou Colour-way New Material Co., Ltd. — 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 | 69256340SLSGNWN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Suzhou Colour-way New Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000027396
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED e9e6ca8d-15a6-4a98-ba80-812e5662c7aa 61 fields · synced Jun 19, 2026