Identity
- Trade Name
- SETINO EUDAMED
- Device Name
- Latex Examination Gloves, Powder Free, Chlorinated, Non-Sterile EUDAMED
- Model / Reference
- LO01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08859130638223 EUDAMED
- Basic UDI-DI
- 88591306LO01V9 EUDAMED
- Unit of Use DI
- 28859130638227 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Setino by Sri Trang Gloves (thailand) Public Company Limited — Class I — 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 | 88591306LO01V9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sri Trang Gloves (Thailand) Public Company Limited
- EUDAMED SRN
- TH-MF-000010448
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 7e38b7a6-cea0-4779-b91d-074304c0ed60 61 fields · synced Jun 19, 2026