Identity
- Trade Name
- IneoGuard EUDAMED
- Device Name
- Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free EUDAMED
- Model / Reference
- IG2 EUDAMEDIG285 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551012401114 EUDAMED
- Basic UDI-DI
- 955101240MODEL27P 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
IneoGuard by Ineo Tech Sdn. Bhd. — 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 | 955101240MODEL27P | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ineo Tech Sdn Bhd
- EUDAMED SRN
- MY-MF-000026701
- Authorised Representative
- Advanced Barrier Solutions SARL FR-AR-000025223
Sources (1)
- EUDAMED 587b7122-96c8-4e6c-aafc-c57ae7289bf1 61 fields · synced Jun 19, 2026