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Biogel® Neoderm®
EUDAMEDClass IIa (EU MDR)
Ref Powder Free Polychloroprene Sterile Surgical Gloves, Size 9.5 (CR-SG-140-WH-AF)Model CHLOROSENSE
Identity
- Trade Name
- Biogel® Neoderm® 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
- 08997030302988 EUDAMED
- Basic UDI-DI
- 899703030CRSGPG EUDAMED
- EMDN Code
- T01010201 POLYCHLOROPREN SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Biogel® Neoderm® 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 e8fe4521-36c9-423a-b21b-e8fe0b668d9b-1 61 fields · synced Jun 19, 2026