Identity
- Trade Name
- Sempermed Syntegra X EUDAMEDBiogel® Radiation Protection Micro FDA UDI
- Generic Name
- Radiation attenuating polyisoprene surgical/procedural glove FDA UDI
- Device Name
- Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free EUDAMEDPolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 1, Size 6 FDA UDI
- Model / Reference
- IG1 EUDAMED3000016263 EUDAMEDModel 1 FDA UDI
- Description
- PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove, Model 1, Size 6 FDA UDI
Identifiers
- Catalog Number
- 52060 FDA UDI
- Primary DI / UDI-DI
- 09551012401145 EUDAMEDFDA UDI
- Basic UDI-DI
- 955101240MODEL17M EUDAMED
- FDA Product Code
- KGO FDA UDI
- EMDN Code
- T01010203 POLYISOPREN SURGICAL GLOVES EUDAMED
- GMDN Term
- Radiation attenuating polyisoprene surgical/procedural glove FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4460 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sempermed Syntegra X by Ineo Tech Sdn. Bhd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955101240MODEL17M | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 3f29954d-337b-4ba8-921c-eed8dba76f1c 61 fields · synced Jul 9, 2026
- FDA UDI f764a6b2-3905-450e-8f5a-4f2556cbadcb 36 fields · synced May 30, 2026