Identity
- Trade Name
- CREATININE PAP SL EUDAMEDFDA UDI
- Generic Name
- Creatinine IVD, kit, spectrophotometry FDA UDI
- Device Name
- CREATININE PAP SL EUDAMED
- Model / Reference
- CRSL-0250 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700819707 EUDAMEDFDA UDI
- Basic UDI-DI
- 37017008CRSL00BJ EUDAMED
- EMDN Code
- W01010207 CREATININE EUDAMED
- GMDN Term
- Creatinine IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France 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
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Creatinine Pap Sl by Vitalscientific — Class B — 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 | 37017008CRSL00BJ | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED a0f29232-db53-441a-a51e-686114ac584a 61 fields · synced May 30, 2026
- FDA UDI a336c4ca-24af-40f0-8a3f-0e7a9b6657b4 32 fields · synced May 30, 2026