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Isosense Protect
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Powder Free Polyisoprene Sterile Surgical Gloves, Size 8.0 (1R-SG-119-DG)Model ISOSENSE510(k) K112654
Identity
- Trade Name
- Isosense Protect EUDAMED
- Device Name
- Powder Free Polyisoprene Sterile Surgical Gloves EUDAMED
- Model / Reference
- ISOSENSE EUDAMEDPowder Free Polyisoprene Sterile Surgical Gloves, Size 8.0 (1R-SG-119-DG) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08997030302384 EUDAMED
- Basic UDI-DI
- 899703030IRSGQS EUDAMED
- EMDN Code
- T01010203 POLYISOPREN 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
Isosense Protect by PT. Medisafe Technologies — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112654 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 899703030IRSGQS | 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 (3)
- EUDAMED 37a6d527-d910-4b6c-b6ea-5c0b2c39a293 85 fields · synced Jun 18, 2026
- EUDAMED 37a6d527-d910-4b6c-b6ea-5c0b2c39a293-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K112654 1 fields · synced May 18, 2026