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Mdf® MDF808M04

by MDF Instruments Medifriend Inc.

Ref MDF808M04Model MDF 808M

Mdf® MDF808M04 is a device classified as Class I in the EU and Class II in the US made by MDF Instruments Medifriend Inc., registered in EUDAMED on 6 Sep 2026 (Basic UDI-DI 69402116808ME3), cleared under FDA 510(k) K950778 on 14 Mar 1995 and listed in FDA GUDID since 31 Dec 2018 (UDI-DI 06940211628096), active as of 9 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 9 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K950778

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69402116808ME3 Basic UDI-DI 06940211628096UDI-DIDate6 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06940211628096 UDI-DI Date31 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK950778 Date14 Mar 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69402116808ME3 registered 6 Sep 2026 Active
  • FDA 510(k) K950778 decided 14 Mar 1995 Active
  • FDA GUDID UDI-DI 06940211628096 listed 31 Dec 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K950778
  2. Listed FDA GUDID 06940211628096
  3. Registered EUDAMED 69402116808ME3

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Mdf®
Generic name
Aneroid manual sphygmomanometer
Device name
MDF® Calibra® Pocket Aneroid Sphygmomanometer
Model / reference
MDF808M04, MDF 808M
Description
Aneroid Sphygmomanometer, Single Bellow, MDF04
Primary DI / UDI-DI
06940211628096
Basic UDI-DI
69402116808ME3
510(k) Number
FDA product code
DXQ
EMDN code
C9006 Aneroid sphygmomanometers
GMDN term
Aneroid manual sphygmomanometer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1120
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Category: Aneroid manual sphygmomanometer

Cleared under the same submission (K950778)

and 8 more cleared under K950778

Similar devices in this category

Other devices filed under ANEROID SPHYGMOMANOMETERS.

Other devices from MDF Instruments Medifriend Inc.

See all devices from MDF Instruments Medifriend Inc. →

Properties

  • Measuring function
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)