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Neotex Purederma
EUDAMEDClass IIa (EU MDR)
Ref Powder Free Polychloroprene Sterile Surgical Gloves, Size 9.5 (CR-SG-140-WH-AF)Model CHLOROSENSE
Identity
- Trade Name
- Neotex Purederma EUDAMED
- Device Name
- Powder Free Polychloroprene Sterile Surgical Gloves EUDAMED
- Model / Reference
- CHLOROSENSE EUDAMEDPowder Free Polychloroprene Sterile Surgical Gloves, Size 9.5 (CR-SG-140-WH-AF) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08997030301981 EUDAMED
- Basic UDI-DI
- 899703030CRSGPG EUDAMED
- EMDN Code
- T01010201 POLYCHLOROPREN SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Neotex Purederma by PT. Medisafe Technologies — 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 | 899703030CRSGPG | Class IIa | Active |
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Manufacturer
- Manufacturer
- PT. Medisafe Technologies
- EUDAMED SRN
- ID-MF-000017133
- Authorised Representative
- Theo Manufacturing B.V. NL-AR-000006691
Sources (1)
- EUDAMED 3042139a-6999-4061-9d0d-8bdeb720ddfb 61 fields · synced Jun 9, 2026