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IneoGuard
EUDAMEDClass IIa (EU MDR)
Ref IG255Model IG2Ref IG275Ref IG270Ref IG175Model IG1Ref IG280Ref IG180Ref IG265Ref IG260Ref IG165
Identity
- Trade Name
- IneoGuard EUDAMED
- Device Name
- Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free EUDAMED
- Model / Reference
- IG2 EUDAMEDIG255 EUDAMEDIG275 EUDAMEDIG270 EUDAMEDIG1 EUDAMEDIG175 EUDAMEDIG280 EUDAMEDIG180 EUDAMEDIG265 EUDAMEDIG260 EUDAMEDIG165 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551012401053 EUDAMED09551012401091 EUDAMED09551012401084 EUDAMED09551012401015 EUDAMED09551012401107 EUDAMED09551012401022 EUDAMED09551012401077 EUDAMED09551012401060 EUDAMED09551012400995 EUDAMED
- Basic UDI-DI
- 955101240MODEL27P EUDAMED955101240MODEL17M 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 |
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Manufacturer
- Manufacturer
- Ineo Tech Sdn Bhd
- EUDAMED SRN
- MY-MF-000026701
- Authorised Representative
- Advanced Barrier Solutions SARL FR-AR-000025223
Sources (9)
- EUDAMED ce38af4e-2982-49c1-8c98-68fcda255180 61 fields · synced Sep 17, 2026
- EUDAMED 736ec911-4d9b-4c24-844f-97485300de31 61 fields · synced May 16, 2026
- EUDAMED f5e9e7a7-8d76-4731-9d28-f07f2605a3f0 61 fields · synced May 17, 2026
- EUDAMED e6988808-d31f-4778-a245-34d8b74b6cb7 61 fields · synced May 17, 2026
- EUDAMED 39a8ba63-876a-4ea6-8317-5956018e246c 61 fields · synced May 17, 2026
- EUDAMED 7bf3a001-dc76-4a9f-a97d-351e9d81e121 61 fields · synced May 17, 2026
- EUDAMED 22894e16-6ce9-4d2e-a29d-e7900c1a8881 61 fields · synced May 18, 2026
- EUDAMED c63dc546-50d4-449f-a8f0-cf34a6bd4277 61 fields · synced May 18, 2026
- EUDAMED 161fb6c7-ae79-4eb5-b593-88bb5e291a5e 61 fields · synced May 18, 2026