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Chlorosense Optima
EUDAMEDClass IIa (EU MDR)
Ref CR-SG-135-LG-CRModel CHLOROSENSERef CR-SG-135-LG-CR
Identity
- Trade Name
- CHLOROSENSE OPTIMA EUDAMED
- Device Name
- Powder Free Polychloroprene Sterile Surgical Gloves EUDAMED
- Model / Reference
- CHLOROSENSE EUDAMEDCR-SG-135-LG-CR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08997030300847 EUDAMED08997030300250 EUDAMED08997030300281 EUDAMED08997030300267 EUDAMED08997030300861 EUDAMED08997030300274 EUDAMED08997030300816 EUDAMED08997030300854 EUDAMED
- Basic UDI-DI
- 899703030CRSGPG EUDAMED
- EMDN Code
- T01010201 POLYCHLOROPREN SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Chlorosense Optima 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 (8)
- EUDAMED 34b765ab-ec5b-45c8-9fbc-9479cbcc5a00 61 fields · synced Aug 3, 2026
- EUDAMED af103068-465d-47b4-a549-18be0f33bfce 61 fields · synced May 16, 2026
- EUDAMED 2ae80c16-4022-40a0-9b52-368b48666b81 61 fields · synced May 16, 2026
- EUDAMED b69cd3c0-a8e9-46d8-9e85-7fa82c6e27ec 61 fields · synced May 16, 2026
- EUDAMED f7bf18bf-3653-4799-847c-a8bbbf8779ee 61 fields · synced May 17, 2026
- EUDAMED d791d6c2-663b-4f3c-b855-cf2ca2d34568 61 fields · synced May 17, 2026
- EUDAMED 5d31ed9c-ea2c-4710-953a-ced3113be855 61 fields · synced May 19, 2026
- EUDAMED 57f33c97-a74a-4727-b0d4-50fd46613249 61 fields · synced May 19, 2026