Identity
- Trade Name
- Heated Breathing Tube EUDAMED
- Device Name
- Heated Breathing Tube EUDAMED
- Model / Reference
- WHT-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971914891203 EUDAMED
- Basic UDI-DI
- 697191489WTH1UE EUDAMED
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Heated Breathing Tube by Guangzhou Hypnus Healthcare 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 | 697191489WTH1UE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Hypnus Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000035782
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2b75efe6-490c-4a58-b8f3-a8c643f84c85 61 fields · synced Jun 11, 2026