Identity
- Trade Name
- B·R·A·H·M·S KRYPTOR BUFFER EUDAMEDB.R.A.H.M.S KRYPTOR BUFFER FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- B·R·A·H·M·S KRYPTOR BUFFER EUDAMED
- Model / Reference
- 89970 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260157638990 EUDAMEDFDA UDI
- Basic UDI-DI
- 426015763899BKBUFFER0XXUR EUDAMED
- FDA Product Code
- JZT FDA UDI
- EMDN Code
- W0201020185 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory 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 Buffer 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 | 426015763899BKBUFFER0XXUR | 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 3adebcc9-a05a-42cc-8231-26d2ad893629 61 fields · synced May 30, 2026
- FDA UDI 4e924096-d305-4993-b3bf-caf2b85ee826 32 fields · synced May 30, 2026