Identity
- Device Name
- DISPOSABLE Waterproof Protector EUDAMED
- Model / Reference
- FM-083 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942272608311 EUDAMED
- Basic UDI-DI
- 69422726P4.01.16XS EUDAMED
- Unit of Use DI
- 06942272608314 EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER 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
No
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
DISPOSABLE Waterproof Protector 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 | 69422726P4.01.16XS | 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 14197131-972b-4bfa-8efa-3602bfda68d7 61 fields · synced Oct 5, 2026