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Arterial Blood Gas Sampler
EUDAMEDClass IIa (EU MDR)
Ref 115356, 115357Model ABS01A-FC, ABS02A-FC, ABS03A-FC
Identity
- Device Name
- Arterial Blood Gas Sampler EUDAMED
- Model / Reference
- ABS01A-FC, ABS02A-FC, ABS03A-FC EUDAMED115356, 115357 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974617172181 EUDAMED
- Basic UDI-DI
- 697461717ABGAFGHE EUDAMED
- EMDN Code
- A02010501 BLOOD GAS ANALYSIS, SYRINGES WITH NEEDLE W/O SAFETY SYSTEM 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 | 697461717ABGAFGHE | 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 5556560a-ed49-4850-8c4e-d3e74c0385bc 61 fields · synced Jun 17, 2026
- EUDAMED 5556560a-ed49-4850-8c4e-d3e74c0385bc-1 61 fields · synced Jun 9, 2026