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Controls
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref Blood Gas and Electrolyte Control Level 3
Identity
- Trade Name
- Controls EUDAMEDBlood Gas and Electrolyte Control FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- Controls EUDAMED
- Model / Reference
- Blood Gas and Electrolyte Control Level 3 EUDAMEDLevel 3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413802001 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06944413802001 EUDAMED
- 510(k) Number
- K151978 FDA UDI
- FDA Product Code
- JJS FDA UDI
- EMDN Code
- W0101050204 ELECTROLYTE CONTROLS EUDAMED
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Controls by Edan Instruments, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06944413802001 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 4ebfdd86-0d0b-4424-8e5d-1af3b2ab5a8d 61 fields · synced Jul 11, 2026
- FDA UDI 55db12c4-f1ca-498b-8115-2a825f456d82 33 fields · synced May 30, 2026