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Challenge Test Pack
EUDAMEDClass I (EU MDR)
Ref HR-SWBModel HR-SWB, or customizedRef HR-TZBModel HR-TZB, or customizedRef HR-ZHBModel HR-ZHB, or customizedRef HR-JZHBModel HR-JZHB, or customizedRef HR-JSBModel HR-JSB, or customized
Identity
- Device Name
- Challenge Test Pack EUDAMED
- Model / Reference
- HR-SWB, or customized EUDAMEDHR-SWB EUDAMEDHR-TZB, or customized EUDAMEDHR-TZB EUDAMEDHR-ZHB, or customized EUDAMEDHR-ZHB EUDAMEDHR-JZHB, or customized EUDAMEDHR-JZHB EUDAMEDHR-JSB, or customized EUDAMEDHR-JSB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978547570260 EUDAMED06978547570253 EUDAMED06978547570284 EUDAMED06978547570291 EUDAMED06978547570277 EUDAMED
- Basic UDI-DI
- 697854757CTP2SWBCX EUDAMED697854757CTP1TZBD6 EUDAMED697854757CTP4ZHBD3 EUDAMED697854757CTP5JZHBSP EUDAMED697854757CTP3JSBBD 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
Challenge Test Pack by Weihai Hengrui New Packaging Materials 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 | 697854757CTP2SWBCX | 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 (5)
- EUDAMED 166c22fd-1d5d-49b7-a895-34d22d952855 61 fields · synced Aug 3, 2026
- EUDAMED 5e2dff6b-5d10-497d-9ebc-77cd46546c65 61 fields · synced May 17, 2026
- EUDAMED 7e797031-c593-4eed-96eb-b4d8f578cdcf 61 fields · synced May 18, 2026
- EUDAMED 861dd8da-4c53-4471-aaf2-13e6f2f6cd47 61 fields · synced May 18, 2026
- EUDAMED d4700d9a-eeb4-438d-912c-5650256dc70a 61 fields · synced May 18, 2026