Identity
- Trade Name
- 903™ EUDAMEDFDA UDI
- Generic Name
- Blood collection paper FDA UDI
- Device Name
- 903 Filter Paper EUDAMEDFDA UDI
- Model / Reference
- W162 / 105xxxxx EUDAMED105 FDA UDI
- Description
- 903 Filter Paper FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860802000345 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039198105VD EUDAMED
- FDA Product Code
- JKA FDA UDI
- EMDN Code
- W0501010299,W05019099 EUDAMED
- GMDN Term
- Blood collection paper FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
903™ by Eastern Business Forms, LLC — 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 | 0850039198105VD | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eastern Business Forms, LLC
- EUDAMED SRN
- US-MF-000047033
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 4f52717c-599f-44e3-a32d-92bbf9ad55e8 61 fields · synced Jul 17, 2026
- FDA UDI bc4e0271-8876-48d9-b872-1f2644e235fa 33 fields · synced May 30, 2026