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TassoOne Plus
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref K1015-01Model K1015-01, K1013-01, K1027-01
by Tasso, Inc.
Identity
- Trade Name
- TassoOne Plus EUDAMEDTasso+ FDA UDI
- Generic Name
- Manual blood lancing device, single-use FDA UDI
- Device Name
- TassoOne Plus, Tasso+, Tasso Mini EUDAMED
- Model / Reference
- K1015-01, K1013-01, K1027-01 EUDAMEDK1015-01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006434595 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850038691TassoLancetK7 EUDAMED
- FDA Product Code
- FMK FDA UDI
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Manual blood lancing device, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- Not 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Category: Blood lancet, single-use
TassoOne Plus by Tasso Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850038691TassoLancetK7 | 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 0a0476a5-f025-4cd2-bfc9-329aaf81499c 61 fields · synced Jul 9, 2026
- FDA UDI e86de501-a1a6-4ae0-97d8-8d66bbb9b667 35 fields · synced May 30, 2026