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B·R·A·H·M·S KRYPTOR compact SOLUTION 4
EUDAMEDFDA UDIClass A (EU MDR)
Ref 89984
Identity
- Trade Name
- B·R·A·H·M·S KRYPTOR compact SOLUTION 4 EUDAMEDB.R.A.H.M.S KRYPTOR compact SOLUTION 4 FDA UDI
- Generic Name
- Buffered wash solution IVD FDA UDI
- Device Name
- B·R·A·H·M·S KRYPTOR compact SOLUTIONS 3 and 4 EUDAMED
- Model / Reference
- 89984 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260157633247 EUDAMEDFDA UDI
- Basic UDI-DI
- 426015763899BKCSol3-4XXFT EUDAMED
- FDA Product Code
- JZT FDA UDI
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Buffered wash solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.4520 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
B·R·A·H·M·S KRYPTOR compact SOLUTION 4 by B.R.A.H.M.S GmbH — 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 | 426015763899BKCSol3-4XXFT | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- B·R·A·H·M·S GmbH
- EUDAMED SRN
- DE-MF-000026030
Sources (2)
- EUDAMED 5245bb9b-57e8-4568-ae4b-197858497e8e 61 fields · synced Jul 16, 2026
- FDA UDI 0ff0d31b-a64d-4098-b1d7-7bce63db54e1 32 fields · synced May 30, 2026