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Endo R
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel 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 -RModel ENMRLG
by B&L Biotech
Identity
- Trade Name
- Endo R EUDAMEDEndo R, M&R FDA UDI
- Generic Name
- Medical ruler, reusable FDA UDI
- Device Name
- Endo M, Endo R, Endo M&R EUDAMEDEndo R EUDAMEDEndo M Ring Large Dark gray FDA UDI
- Model / Reference
- 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 EUDAMEDnone EUDAMEDENMRLG EUDAMEDFDA UDI
- Description
- Endo M Ring Large Dark gray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019140542 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191ENDOLF EUDAMEDB-08800019140542 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- V0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES EUDAMED
- GMDN Term
- Medical ruler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Endo R by B&L Biotech — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 88000191ENDOLF | Class I | Active |
| EUDAMED | European Union | CE/MDR | 88000191ENDOLF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- B&L Biotech
- EUDAMED SRN
- KR-MF-000023296
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 1ec1decf-670d-4bf2-abbc-fe0dbf94548a 61 fields · synced Jul 10, 2026
- EUDAMED 73da166c-36ac-4ce5-9a62-774d5b200261 61 fields · synced May 18, 2026
- FDA UDI 10b11530-126f-43e2-bda9-8843d20b6aef 33 fields · synced May 30, 2026
- EUDAMED 1ec1decf-670d-4bf2-abbc-fe0dbf94548a-1 61 fields · synced Jun 9, 2026