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Tenderfoot Heel Incision Device

by Accriva Diagnostics, Inc. 6 variants

Ref TF200I

Tenderfoot Heel Incision Device (TF200I) is a device classified as Class IIa in the EU and Class II in the US made by Accriva Diagnostics, Inc., registered in EUDAMED on 12 Nov 2025 (Basic UDI-DI 0711234301190LR) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 20711234301194), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0711234301190LR Basic UDI-DI 20711234301194UDI-DIDate12 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number20711234301194 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0711234301190LR registered 12 Nov 2025 Active
  • FDA GUDID UDI-DI 20711234301194 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 20711234301194
  2. Registered EUDAMED 0711234301190LR

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Tenderfoot Heel Incision Device EUDAMED
Tenderfoot Newborn Heel Stick Device GUDID
Generic name
Blood lancet, single-use
Model / Ref / Catalog
TF200I
Primary DI / UDI-DI
20711234301194
Basic UDI-DI
0711234301190LR
Unit of use DI
00711234301190
FDA product code
FMK
EMDN code
V010401 Lancets with safety systems, single-use
GMDN term
Blood lancet, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4850
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Length — 2.50 Millimeter
Depth — 1.00 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000009902
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Blood lancet, single-use

Similar devices in this category

Other devices filed under LANCETS WITH SAFETY SYSTEMS, SINGLE-USE.

Other devices from Accriva Diagnostics, Inc.

See all devices from Accriva Diagnostics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Contains endocrine-disrupting substances
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)