Identity
- Trade Name
- Medical Oxygen-air blenders EUDAMEDMedical Air/Oxygen Blender EUDAMED
- Device Name
- Medical Oxygen-air blenders EUDAMEDMedical Air/Oxygen Blender EUDAMED
- Model / Reference
- KL-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021493 EUDAMED
- Basic UDI-DI
- 69454290KL001MC EUDAMEDB-06945429021493 EUDAMED
- Direct Marketing DI
- 06945429021493 EUDAMED
- EMDN Code
- Z1203019099 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT – OTHER EUDAMEDR03010207 OXYGEN THERAPY KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMEDFinland 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
Medical Oxygen-air blenders by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69454290KL001MC | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 69454290KL001MC | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED f7d7e88b-e632-4420-a8c2-1552fa712043 61 fields · synced Jul 21, 2026
- EUDAMED e4f1b955-aad7-467a-9979-5987dcb6fb07 61 fields · synced May 18, 2026