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Endo M

by B&L Biotech 7 variants

Model ENMSSG

Endo M (ENMSSG) is a medical ruler (EU MDD Class I; FDA Class I; FDA product code EKS, File, Pulp Canal, Endodontic) made by B&L Biotech, registered in EUDAMED on 19 Feb 2025 (Basic UDI-DI B-08800019140481) and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 08800019140481), active as of 22 Oct 2026.

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

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800019140481 Basic UDI-DI 08800019140481UDI-DIDate19 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08800019140481 UDI-DI Date15 Jun 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800019140481 registered 19 Feb 2025 Active
  • FDA GUDID UDI-DI 08800019140481 listed 15 Jun 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800019140481
  2. Registered EUDAMED B-08800019140481

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Endo M EUDAMED
Endo M, M&R GUDID
Generic name
Medical ruler, reusable
Model / reference
ENMSSG
Primary DI / UDI-DI
08800019140481
Basic UDI-DI
B-08800019140481
FDA product code
EKS
EMDN code
V0380 Devices with measuring functions - accessories
GMDN term
Medical ruler, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Legacy device (under a directive)
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08800019140481: EUDAMED states Yes, FDA GUDID states No.

Manufacturer details

EUDAMED SRN
KR-MF-000023296
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Other devices filed under DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES.

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Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Measuring function
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)