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Heated Breathing Circuits
EUDAMEDClass IIa (EU MDR)
Ref AIRT-B6BRef AIRT-B5DRef AIRT-B5BRef AIRT-B4ERef Triton NIV CircuitRef AIRT-B4TRef Triton DT Adult CircuitRef AIRT-B4ARef AIRT-B5ARef AIRT-B4NRef AIRT-B4Ref AIRT-B4N01Ref AIRT-B4HRef AIRT-B4H01Ref AIRT-B6DRef AIRT-B4I
Identity
- Trade Name
- Heated Breathing Circuits EUDAMED
- Device Name
- Heated Breathing Circuits EUDAMED
- Model / Reference
- AIRT-B6B EUDAMEDAIRT-B5D EUDAMEDAIRT-B5B EUDAMEDAIRT-B4E EUDAMEDTriton NIV Circuit EUDAMEDAIRT-B4T EUDAMEDTriton DT Adult Circuit EUDAMEDAIRT-B4A EUDAMEDAIRT-B5A EUDAMEDAIRT-B4N EUDAMEDAIRT-B4 EUDAMEDAIRT-B4N01 EUDAMEDAIRT-B4H EUDAMEDAIRT-B4H01 EUDAMEDAIRT-B6D EUDAMEDAIRT-B4I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957469405065 EUDAMED06957469405010 EUDAMED06957469401234 EUDAMED06957469401326 EUDAMED06957469403931 EUDAMED06957469405041 EUDAMED06957469403955 EUDAMED06957469401210 EUDAMED06957469401227 EUDAMED06957469401319 EUDAMED06957469402187 EUDAMED06957469403979 EUDAMED06957469403894 EUDAMED06957469404723 EUDAMED06957469405089 EUDAMED06957469405027 EUDAMED
- Basic UDI-DI
- 6957469403005E7 EUDAMED
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ventilator breathing circuit, single-use
Heated Breathing Circuits by Shenyang RMS Medical Tech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
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 | 6957469403005E7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenyang RMS Medical Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000023286
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (16)
- EUDAMED f24fe4ce-a932-420f-8c2a-3372011b638c 61 fields · synced Aug 4, 2026
- EUDAMED 96bd6c0d-559f-4d57-a688-face1cb2618e 61 fields · synced May 17, 2026
- EUDAMED ac0f6773-600b-41d3-a06a-a5b16d5fc209 61 fields · synced May 17, 2026
- EUDAMED 4b5f3af9-8400-4d0d-a3c4-e5ba6d0df77c 61 fields · synced May 17, 2026
- EUDAMED d7ea16ba-599f-45cd-a50a-bae7fcc42112 61 fields · synced May 17, 2026
- EUDAMED e2d3e584-db06-48b9-a2e9-0fea8464920b 61 fields · synced May 17, 2026
- EUDAMED 68bb875b-1730-413d-a9ab-5bcfa1e23397 61 fields · synced May 18, 2026
- EUDAMED 20b4e975-9015-4df6-9c3e-c123c1f62afb 61 fields · synced May 18, 2026
- EUDAMED a4bea123-51df-412c-8bbf-e79780654a5f 61 fields · synced May 18, 2026
- EUDAMED a327816f-c073-4201-9fce-87f93e61a312 61 fields · synced May 18, 2026
- EUDAMED 522f5aa2-0f94-4974-b3dc-78a2069807fe 61 fields · synced May 18, 2026
- EUDAMED a930c0f7-1121-47f2-a31d-d1a60ca083ac 61 fields · synced May 18, 2026
- EUDAMED 64050711-c152-46cd-9d47-1d4ed53221e2 61 fields · synced May 18, 2026
- EUDAMED 0237bafe-865f-41f8-bcb1-d5ab58a05de3 61 fields · synced May 18, 2026
- EUDAMED 08945840-1793-4a83-9184-a65421e5e5ba 61 fields · synced May 18, 2026
- EUDAMED b9016b3b-52a3-4395-8ac7-00e07553f505 61 fields · synced May 18, 2026