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Arterial Blood Gas Sampler
EUDAMEDClass IIa (EU MDR)
Ref 112256, 112257Model ABS01S-FC, ABS02S-FC, ABS03S-FC
Identity
- Device Name
- Arterial Blood Gas Sampler EUDAMED
- Model / Reference
- ABS01S-FC, ABS02S-FC, ABS03S-FC EUDAMED112256, 112257 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974617172204 EUDAMED
- Basic UDI-DI
- 697461717ABGFSJN EUDAMED
- EMDN Code
- A02010502 BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Arterial Blood Gas Sampler by Hubei MeterOmega Technology 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 | 697461717ABGFSJN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hubei MeterOmega Technology LTD
- EUDAMED SRN
- CN-MF-000016732
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (2)
- EUDAMED 00a3c620-f7d0-4df5-bfb9-1710f4ca7186 61 fields · synced Jun 17, 2026
- EUDAMED 00a3c620-f7d0-4df5-bfb9-1710f4ca7186-1 61 fields · synced Jun 9, 2026