Identity
- Device Name
- B-D Test Packs EUDAMED
- Model / Reference
- 2240 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971085850108 EUDAMED
- Basic UDI-DI
- 697108585B-DTESTJT EUDAMED
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (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
B-D Test Packs by Hebei Ruihan Medical Equipment 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 | 697108585B-DTESTJT | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Ruihan Medical Equipment Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000048839
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED b9f9db36-537c-4577-a2de-48c357c7d063 61 fields · synced Jun 18, 2026