← Back to catalogue
Disposable Bowie-Dick Test Pack
EUDAMEDClass I (EU MDR)
Ref HR-ⅡBDBModel HR-ⅡBDB, or customizedRef HR-YJBModel HR-YJB, or customized
Identity
- Device Name
- Disposable Bowie-Dick Test Pack EUDAMED
- Model / Reference
- HR-ⅡBDB, or customized EUDAMEDHR-ⅡBDB EUDAMEDHR-YJB, or customized EUDAMEDHR-YJB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978547570123 EUDAMED06978547570130 EUDAMED
- Basic UDI-DI
- 697854757DBDTP2IIBDBHS EUDAMED697854757DBDTP3YJB65 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
Disposable Bowie-Dick 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 | 697854757DBDTP2IIBDBHS | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Weihai Hengrui New Packaging Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000050315
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED cc44907b-b0c1-4a8d-9726-9af83e0acc8e 61 fields · synced Jul 18, 2026
- EUDAMED 202735bf-8950-4461-a4f4-b3370971efc2 61 fields · synced May 19, 2026