Endo R
Part of a family of 26 devices: see the family page
Model ENMSSG-R, ENMSSG-R, ENMMB1-R, ENMMB1-L, ENMSSG, ENMRLG-R, ENMMB2-L, ENMMB2-R, ENMRMG, ENMRLG, ENMRSG, ENMRMG-R, ENMSP, ENMSSGRLG-R, ENMSSGRMG-R, ENMSSGRSG -R, ENMRLG-R
Endo R 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 7 Jan 2025 (Basic UDI-DI 88000191ENDOLF) and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 08800019140122), active as of 22 Oct 2026.
Active
CE MDR CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | Number88000191ENDOLF 08800019140122 | Date7 Jan 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number88000191ENDOLF 08800019140122 | Date7 Jan 2025 | StatusActive |
| United States | GUDID listing GUDID | Number08800019140122 | Date15 Jun 2023 | StatusListed |
Official records
- EUDAMED public site 88000191ENDOLF
- AccessGUDID record 08800019140122
Across registries
- EUDAMED Basic UDI-DI 88000191ENDOLF registered 7 Jan 2025 Active
- FDA GUDID UDI-DI 08800019140122 listed 15 Jun 2023 Listed
Timeline
- Listed FDA GUDID 08800019140122
- Registered EUDAMED 88000191ENDOLF
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic name
- Medical ruler, reusable
- Device name
- Endo M, Endo R, Endo M&R
- Model / reference
- ENMSSG-R, ENMMB1-R, ENMMB1-L, ENMSSG, ENMRLG-R, ENMMB2-L, ENMMB2-R, ENMRMG, ENMRLG, ENMRSG, ENMRMG-R, ENMSP, ENMSSGRLG-R, ENMSSGRMG-R, ENMSSGRSG -R
- Primary DI / UDI-DI
- 08800019140122
- Basic UDI-DI
- 88000191ENDOLF, B-08800019140122
- 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
- Standard deviceLegacy device (under a directive)
- EU market of registration
- Denmark
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- KR-MF-000023296
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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