Identity
- Device Name
- Regulator EUDAMED
- Model / Reference
- BXR01、BXR02、BXR03 EUDAMEDBXR02 EUDAMEDBXR01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971408229710 EUDAMED06971408229703 EUDAMED
- Basic UDI-DI
- 697140822R01M2 EUDAMED
- EMDN Code
- A030104 FLOW REGULATORS 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
Regulator by Hebei Boxin Recovery Equipment 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 | 697140822R01M2 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hebei Boxin Recovery Equipment CO., LTD
- EUDAMED SRN
- CN-MF-000046611
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 602c9018-8bad-44b5-b3ec-1f306630412e 61 fields · synced Oct 6, 2026
- EUDAMED a40f157f-a02f-486c-a982-a5dff54dbf6d 61 fields · synced May 18, 2026