← Back to catalogue
Tasso Mini
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref K1037-01Model K1015-01, K1013-01, K1027-01
by Tasso, Inc.
Identity
- Trade Name
- Tasso Mini EUDAMEDFDA 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 EUDAMEDK1037-01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850038691141 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850038691TassoLancetK7 EUDAMED
- 510(k) Number
- K221131 FDA UDI
- 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
- 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
No
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
Tasso Mini by Tasso Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood lancet, single-use.
- Contact Activated Safety Lancet — NINGBO MEDSUN MEDICAL CO., LTD. · Class IIa
- TysonBio — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Safety Lancet (25G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- Safety Lancet (23G) — Shandong Lianfa Medical Plastic Products CO., LTD · Class II
- STERiLANCE — Sterilance Medical (Suzhou) Inc. · Class IIa
- Lite3 — Sterilance Medical (Suzhou) Inc. · Class IIa
- DropSafe Medlance Plus, safety lancets — HTL STREFA S A · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tasso, Inc.
- EUDAMED SRN
- US-MF-000017355
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 07ad2177-7746-40ed-8667-a8b3d0b414c2 61 fields · synced Jul 10, 2026
- FDA UDI 3da1bd98-1015-469c-b684-59db9d0530e0 35 fields · synced May 30, 2026