Identity
- Trade Name
- Tasso-M20 EUDAMEDFDA UDI
- Generic Name
- Capillary blood collection system IVD FDA UDI
- Device Name
- Tasso-M20 EUDAMEDThe Tasso-M20 is used to collect, store, and transport capillary blood for testing in a centralized laboratory. It is to be used in non-clinical settings for use in adult populations. FDA UDI
- Model / Reference
- K1001-02 EUDAMEDFDA UDI
- Description
- The Tasso-M20 is used to collect, store, and transport capillary blood for testing in a centralized laboratory. It is to be used in non-clinical settings for use in adult populations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006434540 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00860006434540 EUDAMED
- FDA Product Code
- NNK FDA UDIFMK FDA UDI
- EMDN Code
- W0501010201 CAPILLARY BLOOD COLLECTION SYSTEMS EUDAMED
- GMDN Term
- Capillary blood collection system IVD FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI878.4850 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Radiation Sterilization FDA UDI
Tasso-M20 by Tasso Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00860006434540 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 ec9d6195-b5ff-434d-ba5c-3e1f8e8da8e6 61 fields · synced Jun 18, 2026
- FDA UDI 95985f1e-7b2b-4060-ad10-9e446d8847f7 35 fields · synced May 30, 2026