Identity
- Trade Name
- Breathing Tube EUDAMED
- Device Name
- Breathing tubes EUDAMED
- Model / Reference
- HP1，BP1 EUDAMEDTCF-74; Version:A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949932125 EUDAMED
- Basic UDI-DI
- 6958949974K3 EUDAMED
- EMDN Code
- R02010401 CPAP CIRCUITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Breathing Tube by Hunan Beyond Medical Technology Co., Ltd. — Class IIa — 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 | 6958949974K3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Beyond Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002143
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 4f54b9b5-9f8c-4f16-88e0-6f846c085fed 61 fields · synced Jun 19, 2026
- EUDAMED 4f54b9b5-9f8c-4f16-88e0-6f846c085fed-1 61 fields · synced Jun 10, 2026