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Batch Control Helix Test Kit
EUDAMEDClass I (EU MDR)
Ref PCD201Model PCD201 PCD102 PCD302 PCD402 PCD103 PCD202
Identity
- Device Name
- Batch Control Helix Test Kit EUDAMED
- Model / Reference
- PCD201 PCD102 PCD302 PCD402 PCD103 PCD202 EUDAMEDPCD201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978563510608 EUDAMED
- Basic UDI-DI
- 697856351BCHTK01WT EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (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
Batch Control Helix Test Kit by Nantong Ineuthink Medical 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 | 697856351BCHTK01WT | Class I | Active |
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Manufacturer
- Manufacturer
- Nantong Ineuthink Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000047513
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED da80be2d-9c10-4c15-b10e-62516840d5a5 61 fields · synced Jun 18, 2026