Identity
- Trade Name
- Peha-Soft® Latex Comfort S EUDAMED
- Device Name
- Latex Examination Gloves, Powder Free, Chlorinated, Non-Sterile EUDAMED
- Model / Reference
- LO02 EUDAMED9420210 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08859130648918 EUDAMED
- Basic UDI-DI
- 88591306LO02VB EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Peha-Soft® Latex Comfort S 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 | 88591306LO02VB | 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 f7bd492d-52d3-4cc8-8528-4e58f460c563 61 fields · synced Oct 7, 2026