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Tile-T20
EUDAMEDFDA UDIClass A (EU MDR)
Ref PN0583-02Model Tasso Tile
by Tasso, Inc.
Identity
- Trade Name
- Tile-T20 EUDAMEDFDA UDI
- Generic Name
- Dried blood spot collection receptacle IVD FDA UDI
- Model / Reference
- Tasso Tile EUDAMEDPN0583-02 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850038691110 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850038691TassoTileQE EUDAMED
- FDA Product Code
- NNK FDA UDI
- EMDN Code
- W0501010299 CAPILLARY BLOOD COLLECTION DEVICES - OTHER EUDAMED
- GMDN Term
- Dried blood spot collection receptacle IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Netherlands 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
Tile-T20 by Tasso Inc. — 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 | 0850038691TassoTileQE | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Tasso, Inc.
- EUDAMED SRN
- US-MF-000017355
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0f6f246d-b90d-464c-bce2-329af2713978 61 fields · synced Jul 10, 2026
- FDA UDI 2b2fa692-0098-4b40-8a4d-4242d4d7fa94 34 fields · synced May 30, 2026