Identity
- Trade Name
- B·R·A·H·M·S PlGF plus KRYPTOR EUDAMEDB.R.A.H.M.S PlGF plus KRYPTOR FDA UDI
- Generic Name
- Placental growth factor (PLGF) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- B·R·A·H·M·S PlGF plus KRYPTOR EUDAMED
- Model / Reference
- 859075N EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260157632196 EUDAMEDFDA UDI
- Basic UDI-DI
- 426015763859BPlGFpluKXXKY EUDAMED
- 510(k) Number
- DEN220027 FDA UDI
- FDA Product Code
- QWH FDA UDI
- EMDN Code
- W0102050211 PLACENTAL GROWTH FACTOR (PRE-ECLAMPSIA) EUDAMED
- GMDN Term
- Placental growth factor (PLGF) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1602 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
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
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
No
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 PlGF plus KRYPTOR by B.R.A.H.M.S GmbH — Class C — 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 | 426015763859BPlGFpluKXXKY | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- B·R·A·H·M·S GmbH
- EUDAMED SRN
- DE-MF-000026030
Sources (2)
- EUDAMED bada91ae-5664-4262-8763-7c5bba46bd27 61 fields · synced Jun 19, 2026
- FDA UDI 378102ae-4a34-445e-9216-48099d5da3af 33 fields · synced May 30, 2026