Identity
- Device Name
- Fast response kit EUDAMED
- Model / Reference
- WAP-3034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975033060052 EUDAMED
- Basic UDI-DI
- 697503306WAP-3034NZ EUDAMED
- EMDN Code
- T0203 DRESSING AND ASSISTANCE KITS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Fast response kit by Shenzhen WAP-health Technology Co.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 | 697503306WAP-3034NZ | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen WAP-health Technology Co.Ltd
- EUDAMED SRN
- CN-MF-000041613
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (1)
- EUDAMED 3896e9ee-6b88-43a2-a619-bb2a27a0249f 61 fields · synced Jul 22, 2026