Identity
- Trade Name
- B·R·A·H·M·S PCT sensitive KRYPTOR CAL EUDAMED
- Device Name
- B·R·A·H·M·S PCT sensitive KRYPTOR CAL EUDAMED
- Model / Reference
- 082591N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260157631458 EUDAMED
- Basic UDI-DI
- 426015763825BPCTsKCALXXAZ EUDAMED
- EMDN Code
- W0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
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
B·R·A·H·M·S PCT sensitive KRYPTOR CAL by B.R.A.H.M.S GmbH — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 426015763825BPCTsKCALXXAZ | Class C | Active |
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Manufacturer
- Manufacturer
- B·R·A·H·M·S GmbH
- EUDAMED SRN
- DE-MF-000026030
Sources (1)
- EUDAMED bb14645a-42e9-4ee5-a433-22d9a94dd7cf 61 fields · synced Oct 6, 2026