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Disposable heated breathing circuits
EUDAMEDClass IIb (EU MDR)
Ref AH11008Model AH
Identity
- Trade Name
- Disposable heated breathing circuits EUDAMED
- Device Name
- Disposable heated breathing circuits EUDAMED
- Model / Reference
- AH EUDAMEDAH11008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941850825839 EUDAMED
- Basic UDI-DI
- 69418508AHEL EUDAMED
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
Classification
- Device Class
- Class IIb 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
Category: Ventilator breathing circuit, single-use
Disposable heated breathing circuits by Ningbo Huakun Medical Equipment Co., Ltd — Class IIb — 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 | 69418508AHEL | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ningbo Huakun Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008459
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 9ac8cf71-43b6-4218-95e2-69c3df555cbe 61 fields · synced Jul 8, 2026