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Arterial Blood Gas Sampler
EUDAMEDClass IIa (EU MDR)
Ref 119357Model ABS01, ABS02, ABS03
Identity
- Device Name
- Arterial Blood Gas Sampler EUDAMED
- Model / Reference
- ABS01, ABS02, ABS03 EUDAMED119357 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974617172402 EUDAMED
- Basic UDI-DI
- 697461717syringeABG-GV4 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 | 697461717syringeABG-GV4 | 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 (1)
- EUDAMED 2ef89383-5a69-4fd5-83ef-9b8ac9059711 61 fields · synced Jun 19, 2026