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Batch Control Helix Test Kit
EUDAMEDClass I (EU MDR)
Ref PCD402Model PCD201 PCD102 PCD302 PCD402 PCD103 PCD202Ref PCD202Ref PCD102Ref PCD302
Identity
- Device Name
- Batch Control Helix Test Kit EUDAMED
- Model / Reference
- PCD201 PCD102 PCD302 PCD402 PCD103 PCD202 EUDAMEDPCD402 EUDAMEDPCD202 EUDAMEDPCD102 EUDAMEDPCD302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978563510219 EUDAMED06978563510233 EUDAMED06978563510189 EUDAMED06978563510196 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
Category: Sterilizer/disinfector rack
Batch Control Helix Test Kit by Nantong Ineuthink Medical Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (4)
- EUDAMED 7db2df22-4897-4124-a991-1e28a65d2d95 61 fields · synced Jul 30, 2026
- EUDAMED 25d8e435-92d7-4fc0-b83d-9b3ef0454bc4 61 fields · synced May 17, 2026
- EUDAMED c6104b7a-f38e-4f07-9c70-df1194f77fab 61 fields · synced May 18, 2026
- EUDAMED 8d7172c7-a235-4fa3-8fa2-f70e0dccb98b 61 fields · synced May 18, 2026