Identity
- Trade Name
- Blood Gas and Chemistry Analyzer EUDAMEDFDA UDI
- Generic Name
- Metabolic profile clinical chemistry analyser IVD, stationary, semi-automated FDA UDI
- Device Name
- Blood Gas and Chemistry Analyzer EUDAMED
- Model / Reference
- i15 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413801875 EUDAMEDFDA UDI
- Basic UDI-DI
- 69444138i15SVA EUDAMED
- 510(k) Number
- K151978 FDA UDI
- FDA Product Code
- GLK FDA UDIJJS FDA UDIJIX FDA UDIGKF FDA UDIJFP FDA UDICGZ FDA UDICEM FDA UDIJGS FDA UDICHL FDA UDI
- EMDN Code
- W0201040101 BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes) EUDAMED
- GMDN Term
- Metabolic profile clinical chemistry analyser IVD, stationary, semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.8625 FDA UDI862.1660 FDA UDI862.1150 FDA UDI864.5600 FDA UDI862.1145 FDA UDI862.1170 FDA UDI862.1600 FDA UDI862.1665 FDA UDI862.1120 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Blood Gas and Chemistry Analyzer by Edan Instruments, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69444138i15SVA | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 90319ea6-5d1e-43b8-ab9c-d6393fe89d61 61 fields · synced Jul 9, 2026
- FDA UDI 7299c48f-9aa8-4587-ba41-ba56822db901 33 fields · synced May 30, 2026