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Respiratory High-Flow Therapy Device
EUDAMEDClass IIa (EU MDR)
Ref HT80SU2Ref HT90FU2Ref HT80FM2
Identity
- Trade Name
- Respiratory High-Flow Therapy Device EUDAMED
- Device Name
- Respiratory High-Flow Therapy Device EUDAMED
- Model / Reference
- HT80SU2 EUDAMEDHT90FU2 EUDAMEDHT80FM2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948538369135 EUDAMED06948538369128 EUDAMED06948538369104 EUDAMED
- Basic UDI-DI
- 69485383HF001PQ EUDAMED
- Direct Marketing DI
- 06948538369135 EUDAMED06948538369128 EUDAMED06948538369104 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Respiratory High-Flow Therapy Device by BMC Medical 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 | 69485383HF001PQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- BMC Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000010157
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 802697f9-343f-4bc3-bf4c-7046b9e0b8bb 61 fields · synced Jul 14, 2026
- EUDAMED 92db1f70-9750-438a-9866-98e69a14f8a3 61 fields · synced May 18, 2026
- EUDAMED ee55ed22-d989-4ee7-bbbe-06e2e1592752 61 fields · synced May 19, 2026