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Calibrant Fluid Pack
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref CP100Ref i20CP300Ref CP50Ref i20CP50510(k) K151978
Identity
- Trade Name
- Calibrant Fluid Pack EUDAMED
- Device Name
- Calibrant Fluid Pack EUDAMED
- Model / Reference
- CP100 EUDAMEDi20CP300 EUDAMEDCP50 EUDAMEDi20CP50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413816282 EUDAMED06944413807341 EUDAMED06944413815254 EUDAMED06944413816312 EUDAMED06944413816275 EUDAMED06944413802599 EUDAMED06944413815193 EUDAMED06944413803107 EUDAMED06944413816329 EUDAMED06944413847477 EUDAMED06944413816305 EUDAMED06944413816299 EUDAMED06944413815186 EUDAMED06944413815247 EUDAMED
- Basic UDI-DI
- B-06944413816282 EUDAMEDB-06944413807341 EUDAMEDB-06944413815254 EUDAMEDB-06944413816312 EUDAMEDB-06944413816275 EUDAMEDB-06944413802599 EUDAMEDB-06944413815193 EUDAMEDB-06944413803107 EUDAMEDB-06944413816329 EUDAMEDB-06944413847477 EUDAMEDB-06944413816305 EUDAMEDB-06944413816299 EUDAMEDB-06944413815186 EUDAMEDB-06944413815247 EUDAMED
- 510(k) Number
- K151978 FDA 510(k)
- FDA Product Code
- CHL FDA 510(k)
- EMDN Code
- W0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1120 FDA 510(k)
- Regulation Number
- 862.1120 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Calibrant Fluid Pack by Edan Instruments, Inc. — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151978 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06944413816282 | Class IVD General | Active |
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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 729bccec-01cb-4f18-8465-d32c9aa98c0d 61 fields · synced Sep 17, 2026
- EUDAMED a3c42bf3-0094-451f-9332-250a7a9e5630 61 fields · synced May 16, 2026
- EUDAMED af303055-ceaa-4491-8716-160683e16093 61 fields · synced May 17, 2026
- EUDAMED 4206e9f1-9c4a-4023-a56b-a4978e3edb11 61 fields · synced May 17, 2026
- EUDAMED 07c9e09b-d2f0-4466-a829-6289a4b1a8ff 61 fields · synced May 17, 2026
- EUDAMED 7b5bb140-af0e-4d4e-a4e0-62862c68c1ed 61 fields · synced May 17, 2026
- EUDAMED 76712b39-1c3e-40a5-af28-f1c6df8972f4 61 fields · synced May 17, 2026
- EUDAMED 50c0c8c7-7fe8-477d-90a1-6749cff60e12 61 fields · synced May 17, 2026
- EUDAMED b4f5daa9-21c6-4e0e-819a-d355b33d5aad 61 fields · synced May 17, 2026
- FDA 510(k) K151978 24 fields · synced May 18, 2026
- EUDAMED 779fa2b5-a74b-4fc3-a75c-5d54b5b1d70f 61 fields · synced Jul 9, 2026
- EUDAMED 11d3e3fe-b799-4678-a96b-1a401df5e5bc 61 fields · synced Jul 10, 2026
- EUDAMED 9d6f15d6-dfc5-421e-a46e-0eb491601403 61 fields · synced Jul 11, 2026
- EUDAMED fe1fce29-a1d7-4b83-8a32-a265c067ec2f 61 fields · synced Jul 17, 2026
- EUDAMED 2988c772-20a5-456a-958a-c823b41f4ca9 61 fields · synced Jul 30, 2026