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Tap

by YourBio Health Inc.

Ref 773112, 770102, 771202, 773102510(k) K223201

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223201↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850057585049 Basic UDI-DI Date21 Jul 2025RegisteredStatusActive
United StatesFDA 510(k)SESU 510(k) Traditional NumberK223201 Date19 Apr 2023ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Device Name
TAP Micro Blood Collection Device - Serum CE
TAP Micro Select
TAP Micro Blood Collection Device - LiHep CE
TAP Micro Blood Collection Device - Serum Gel CE
Model / Reference
773112, 770102, 771202, 773102
Primary DI / UDI-DI
00850057585049, 00850057585100, 00850057585001, 00850057585063
Basic UDI-DI
B-00850057585049, B-00850057585100, B-00850057585001, B-00850057585063
510(k) Number
FDA Product Code
FMK
EMDN Code
W0501010201 Capillary blood collection systems
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 878.4850
EU market of registration
Netherlands
Advisory Committee
General, Plastic Surgery
FDA Decision
SESU

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Manufacturer details

EUDAMED SRN
US-MF-000040029
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Properties

  • Sterile
  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Incorporates Medicinal Product NoEUDAMEDYesEUDAMED

Other properties (8)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No