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Controls
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref CO-Oximeter Control Level 1Ref Blood Gas and Electrolyte Control Level 3Ref CO-Oximeter Control Level 2Ref Blood Gas and Electrolyte Control Level 1Ref Hematocrit Control LowRef CO-Oximeter Control Level 3Ref Hematocrit Control HighRef Blood Gas and Electrolyte Control Level 2
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
- CO-Oximeter Control Level 1 EUDAMEDBlood Gas and Electrolyte Control Level 3 EUDAMEDCO-Oximeter Control Level 2 EUDAMEDBlood Gas and Electrolyte Control Level 1 EUDAMEDHematocrit Control Low EUDAMEDCO-Oximeter Control Level 3 EUDAMEDHematocrit Control High EUDAMEDBlood Gas and Electrolyte Control Level 2 EUDAMEDLevel 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944413847552 EUDAMED06944413847538 EUDAMED06944413815650 EUDAMED06944413847514 EUDAMED06944413809116 EUDAMED06944413847576 EUDAMED06944413809123 EUDAMED06944413801998 EUDAMEDFDA UDI06944413809079 EUDAMED06944413815582 EUDAMED06944413815643 EUDAMED06944413847569 EUDAMED06944413815599 EUDAMED
- Basic UDI-DI
- B-06944413847552 EUDAMEDB-06944413847538 EUDAMEDB-06944413815650 EUDAMEDB-06944413847514 EUDAMEDB-06944413809116 EUDAMEDB-06944413847576 EUDAMEDB-06944413809123 EUDAMEDB-06944413809079 EUDAMEDB-06944413815582 EUDAMEDB-06944413815643 EUDAMEDB-06944413847569 EUDAMEDB-06944413815599 EUDAMEDB-06944413801998 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-06944413847552 | 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 (15)
- EUDAMED 8c66d92e-14a1-4ba0-9177-4c946d080539 61 fields · synced Aug 1, 2026
- EUDAMED c11afc90-708f-48df-8bb4-04f50242289b 61 fields · synced May 16, 2026
- EUDAMED 6e1ff324-9966-4f1c-8b1d-4c5ee5529a0a 61 fields · synced May 17, 2026
- EUDAMED 645914a3-e637-46b0-ac4c-ee94798010e8 61 fields · synced May 17, 2026
- EUDAMED fa8c6b88-2d80-477b-9d6b-6176861874e4 61 fields · synced May 17, 2026
- EUDAMED a7dbdf70-5faf-47f9-a83e-136348d1a760 61 fields · synced May 17, 2026
- EUDAMED 32408ac0-43c4-4c42-b4a6-6f6c96318c8b 61 fields · synced May 18, 2026
- FDA UDI df245040-99f9-4ba2-959f-ca8525ae3f11 33 fields · synced May 30, 2026
- EUDAMED 9c80aa7c-2f29-488d-b079-c14035d0018a 61 fields · synced Jul 10, 2026
- EUDAMED 72b6c5e2-477b-47ba-a535-ba34c37e072e 61 fields · synced Jul 10, 2026
- EUDAMED a6b5f69a-2704-42b6-ade3-4d739c83e13b 61 fields · synced Jul 16, 2026
- EUDAMED 93a6e18b-c7fc-4d39-a3e3-8422a45c1b93 61 fields · synced Jul 21, 2026
- EUDAMED e765f4f6-2725-4255-a445-5112fb0cb328 61 fields · synced Jul 25, 2026
- EUDAMED bf7ba9f3-9368-48c6-ae6e-065a1343bda5 61 fields · synced Jul 30, 2026
- EUDAMED 977bd705-f4dc-4b7b-a20e-33dc49cbd774 61 fields · synced Aug 1, 2026