Identity
- Device Name
- Breathing tubes EUDAMED
- Model / Reference
- HT1 EUDAMEDHP1，BP1 EUDAMED3205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949917047 EUDAMED06958949932057 EUDAMED
- Basic UDI-DI
- 6958949935JR EUDAMED6958949974K3 EUDAMED
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland 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
Category: Ventilator breathing circuit, single-use
Breathing tubes by Hunan Beyond Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ventilator breathing circuit, single-use.
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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 | 6958949935JR | 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 4072a0b0-5f8c-4cdd-8054-8cdc2c3328aa 61 fields · synced Jul 19, 2026
- EUDAMED 62bca621-aedf-4ba4-8355-bd1d0c7d8dbb 61 fields · synced May 17, 2026