Identity
- Trade Name
- B·R·A·H·M·S uE3 KRYPTOR QC EUDAMEDB·R·A·H·M·S uE3 KRYPTOR EUDAMED
- Device Name
- B·R·A·H·M·S uE3 KRYPTOR QC EUDAMEDB·R·A·H·M·S uE3 KRYPTOR EUDAMED
- Model / Reference
- 080392N EUDAMED803075N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260157630635 EUDAMED04260157631847 EUDAMED
- Basic UDI-DI
- 426015763803BuE3KQC00XXRL EUDAMED426015763803BuE3K0000XX6E EUDAMED
- EMDN Code
- W0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMEDW0102050203 UNCONJUGATED (FREE) ESTRIOL EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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 uE3 KRYPTOR QC 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 | 426015763803BuE3KQC00XXRL | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B·R·A·H·M·S GmbH
- EUDAMED SRN
- DE-MF-000026030
Sources (2)
- EUDAMED 1fa07f8c-c4b5-4570-9d41-a8694e3aba4b 61 fields · synced Oct 7, 2026
- EUDAMED 9c39e405-d656-440f-b251-4621e434696b 61 fields · synced May 18, 2026