Identity
- Trade Name
- Tenderfoot EUDAMEDTenderfoot Newborn Heel Stick Device FDA UDI
- Generic Name
- Blood lancet, single-use FDA UDI
- Device Name
- Tenderfoot Newborn EUDAMEDTenderfoot Newborn Heel Stick Device 200/box FDA UDI
- Model / Reference
- TF200I EUDAMEDFDA UDI
- Description
- Tenderfoot Newborn Heel Stick Device 200/box FDA UDI
Identifiers
- Catalog Number
- TF200I FDA UDI
- Primary DI / UDI-DI
- 20711234301194 EUDAMEDFDA UDI
- Basic UDI-DI
- 0711234301190LR EUDAMED
- Unit of Use DI
- 00711234301190 EUDAMED
- FDA Product Code
- FMK FDA UDI
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Blood lancet, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4850 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
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
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
Dimensions & Sizes
- Size
- Length — 2.50 Millimeter FDA UDIDepth — 1.00 Millimeter FDA UDI
Category: Blood lancet, single-use
Tenderfoot by Accriva Diagnostics, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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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 | 0711234301190LR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Accriva Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000009902
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 1a9cae50-bf49-4498-a2a4-7af273e7deaa 61 fields · synced Jul 14, 2026
- FDA UDI fe6ab376-8396-48e0-acb4-1897c575c67b 36 fields · synced May 30, 2026