Identity
- Trade Name
- FLEXCEL LATEX GLOVES Powder Free EUDAMED
- Device Name
- Latex Examination Gloves, Powder Free, Chlorinated, Non-Sterile EUDAMED
- Model / Reference
- LO01 EUDAMEDGL229M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08859130655404 EUDAMED
- Basic UDI-DI
- 88591306LO01V9 EUDAMED
- Unit of Use DI
- 28859130655408 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
FLEXCEL LATEX GLOVES Powder Free by Sri Trang Gloves (thailand) Public Company Limited — Class I — CE/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 |
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Manufacturer
- Manufacturer
- Sri Trang Gloves (Thailand) Public Company Limited
- EUDAMED SRN
- TH-MF-000010448
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 964b8ae8-f315-402d-a31a-42e32d17f376 61 fields · synced Oct 7, 2026