Identity
- Trade Name
- 903™ EUDAMEDFDA UDI
- Generic Name
- Blood collection paper FDA UDI
- Device Name
- 903 Filter Paper EUDAMED
- Model / Reference
- 105xxxxx EUDAMEDW251 / 105xxxxx EUDAMEDW231 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039198045 EUDAMEDFDA UDI00850039198052 EUDAMED
- 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 |
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Manufacturer
- Manufacturer
- Eastern Business Forms, LLC
- EUDAMED SRN
- US-MF-000047033
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED 8a820814-afd7-4820-b74d-f432df81de91 61 fields · synced Jul 10, 2026
- EUDAMED 1bd48ae1-61be-4253-b64c-cc9acd17b4f4 61 fields · synced May 19, 2026
- FDA UDI d251de62-adf5-4474-980a-5cc1290037d5 32 fields · synced May 30, 2026