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Helix PCD Test Set
EUDAMEDClass I (EU MDR)
Ref HR-DZZ-1Model HR-DZZ-1, HR-DZZ-2, or customizedRef HR-GZZModel HR-GZZ, or customizedRef HR-DZZ-2
Identity
- Device Name
- Helix PCD Test Set EUDAMED
- Model / Reference
- HR-DZZ-1, HR-DZZ-2, or customized EUDAMEDHR-DZZ-1 EUDAMEDHR-GZZ, or customized EUDAMEDHR-GZZ EUDAMEDHR-DZZ-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978547570239 EUDAMED06978547570222 EUDAMED06978547570246 EUDAMED
- Basic UDI-DI
- 697854757HPTS2DZZZU EUDAMED697854757HPTS1GZZ27 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
Helix PCD Test Set by Weihai Hengrui New Packaging Materials 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 | 697854757HPTS2DZZZU | Class I | Active |
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Manufacturer
- Manufacturer
- Weihai Hengrui New Packaging Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000050315
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 377d7feb-c777-492d-a924-1bcb69bd51bf 61 fields · synced Jul 23, 2026
- EUDAMED 9122213e-fc44-4b98-a3fa-b0486b1cd5bb 61 fields · synced May 17, 2026
- EUDAMED d6379605-daec-43a2-8f06-0c306adae9f8 61 fields · synced May 19, 2026