Identity
- Trade Name
- Sempermed Syntegra X EUDAMED
- Device Name
- Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free EUDAMED
- Model / Reference
- IG2 EUDAMED3000016276 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551012401275 EUDAMED
- Basic UDI-DI
- 955101240MODEL27P EUDAMED
- EMDN Code
- T01010203 POLYISOPREN SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Sempermed Syntegra X 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 (1)
- EUDAMED 61091b52-7175-415b-8229-be0124acfaee 61 fields · synced Jun 18, 2026