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Pcd/Helix Test Set
EUDAMEDClass I (EU MDR)
Ref plastic head 1.5mModel Plastic head，Metal head
Identity
- Device Name
- PCD/HELIX TEST SET EUDAMED
- Model / Reference
- Plastic head，Metal head EUDAMEDplastic head 1.5m EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974409692194 EUDAMED
- Basic UDI-DI
- 697440969PCD/HELIXRL EUDAMED
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Pcd/Helix Test Set by Mediwish 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 | 697440969PCD/HELIXRL | Class I | Active |
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Manufacturer
- Manufacturer
- Mediwish Co., Ltd
- EUDAMED SRN
- CN-MF-000008849
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 7a9cd749-d465-49ad-ac0c-f73402d50d7c 61 fields · synced Jun 19, 2026