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OsteoProbe

by Active Life Scientific, Inc.

Ref OP-100

OsteoProbe (OP-100) is a medical device (EU MDR Class IIa; EMDN category measurement devices) made by Active Life Scientific, Inc., registered in EUDAMED on 2 Dec 2025 (Basic UDI-DI 00860001719369AW), cleared under FDA 510(k) K250216 on 11 Sep 2025 (1 earlier submission) and granted FDA De Novo DEN210013 on 19 Aug 2021, active as of 24 Oct 2026.

Active European Union and United States

CE MDR 510(k) De Novo

Valid until

No date given

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) K250216↗

+2 more

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00860001719369AW Basic UDI-DI 00860001719369UDI-DIDate2 Dec 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK250216 Date11 Sep 2025IssuedStatusActive
United StatesFDA De Novo De Novo NumberDEN210013 Date19 Aug 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 00860001719369AW registered 2 Dec 2025 Active
  • FDA 510(k) K250216 decided 11 Sep 2025 Active· +1 more in the status table
  • FDA De Novo DEN210013 decided 19 Aug 2021 Active

Timeline

4 dated events

  1. Granted FDA De Novo DEN210013
  2. Cleared FDA 510(k) K221195
  3. Cleared FDA 510(k) K250216
  4. Registered EUDAMED 00860001719369AW

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
OP-100
Primary DI / UDI-DI
00860001719369
Basic UDI-DI
00860001719369AW
EMDN code
V0399 Measurement devices - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000022740
Authorised representative
MedEnvoy Global BV NL-AR-000024028

Similar devices in this category

Other devices filed under MEASUREMENT DEVICES - OTHER.

Other devices from Active Life Scientific, Inc.

Properties

  • Measuring function
Other properties (13, all answered No)