Identity
- Trade Name
- IVD Sample Collection Kit EUDAMEDRDA Spot FDA UDI
- Generic Name
- Capillary blood collection kit IVD FDA UDI
- Device Name
- IVD Sample Collection Kit EUDAMED
- Model / Reference
- RDA001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04779054720108 EUDAMEDFDA UDI
- Basic UDI-DI
- 477905472RDA001EM EUDAMED
- Direct Marketing DI
- 04779054720108 EUDAMED
- FDA Product Code
- PQD FDA UDI
- EMDN Code
- W0501010199,W0501010299 EUDAMED
- GMDN Term
- Capillary blood collection kit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Market of Registration
- Lithuania 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
MR Unsafe FDA UDI
IVD Sample Collection Kit by Rda Spot, Uab — 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 | 477905472RDA001EM | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- RDA Spot, UAB
- EUDAMED SRN
- LT-MF-000027300
Sources (2)
- EUDAMED e2af5073-c551-44cb-8d5f-a120c27ef9cf 61 fields · synced Jul 20, 2026
- FDA UDI f55e6135-22d5-437e-b708-550e15eae6f7 32 fields · synced May 29, 2026