Identity
- Trade Name
- Mediskin EUDAMED
- Device Name
- Latex Powder-free Exam Gloves EUDAMED
- Model / Reference
- TG12 EUDAMEDTG05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14897122904865 EUDAMED14897122904841 EUDAMED
- Basic UDI-DI
- 489712290LaExglovePF5J EUDAMED
- Unit of Use DI
- 04897122904868 EUDAMED04897122904844 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
Mediskin by Fleming Medical Ltd. — 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 | 489712290LaExglovePF5J | Class I | Active |
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Manufacturer
- Manufacturer
- Fleming Medical Ltd.
- EUDAMED SRN
- CN-MF-000014750
- Authorised Representative
- Fleming Medical IE-AR-000012571
Sources (2)
- EUDAMED 035cc9e0-908d-4c16-a477-4783797f0430 61 fields · synced Jul 25, 2026
- EUDAMED 5c78b495-5707-422f-9d9e-a2df74b546ec 61 fields · synced May 19, 2026