Identity
- Trade Name
- MEDICAL GLOVES EUDAMED
- Device Name
- MEDICAL GLOVES EUDAMED
- Model / Reference
- FS-348 S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942272603487 EUDAMED
- Basic UDI-DI
- 69422726P4.04.01Y2 EUDAMED
- EMDN Code
- T01010101 POWDERED LATEX SURGICAL 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
Medical Gloves by FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU) — 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 | 69422726P4.04.01Y2 | Class I | Active |
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Manufacturer
- Manufacturer
- FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
- EUDAMED SRN
- CN-MF-000009645
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED c3bbb36e-77d2-4dcd-852d-8788153477af 61 fields · synced Oct 7, 2026