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Manufix Sensitive
EUDAMEDClass I (EU MDR)
Ref 9209499Model LC01Ref 9209484Ref 9209441
Identity
- Trade Name
- Manufix Sensitive EUDAMED
- Device Name
- Latex Examination Gloves, Powder Free, Polymer Coated, Non-Sterile EUDAMED
- Model / Reference
- LC01 EUDAMED9209499 EUDAMED9209484 EUDAMED9209441 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08859130616894 EUDAMED08859130616887 EUDAMED08859130616863 EUDAMED
- Basic UDI-DI
- 88591306LC01TD EUDAMED
- Unit of Use DI
- 28859130616898 EUDAMED28859130616881 EUDAMED28859130616867 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
Manufix Sensitive 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 | 88591306LC01TD | 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 (3)
- EUDAMED 679485a7-0510-4bf7-90e8-5f87439e7774 61 fields · synced Oct 6, 2026
- EUDAMED fb3eda7d-150d-4d6b-b4d6-9af91937d120 61 fields · synced May 18, 2026
- EUDAMED 60aa71df-29e1-4a97-99ae-3019bd940692 61 fields · synced May 19, 2026