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Bp5508
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref noneModel CL-A1Ref BP5508L
by B&L Biotech
Identity
- Trade Name
- BP5508 EUDAMEDBP5508L EUDAMEDPlugger FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- SuperEndo-Alpha II EUDAMED
- Model / Reference
- CL-A1 EUDAMEDnone EUDAMEDBP5508L EUDAMEDBP5508 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019100218 EUDAMEDFDA UDI08800019100188 EUDAMED
- Basic UDI-DI
- 88000191ALPHAFS EUDAMEDB-08800019100188 EUDAMED
- FDA Product Code
- EKR FDA UDI
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Bp5508 by B&L Biotech — Class IIa — 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 | 88000191ALPHAFS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000191ALPHAFS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 cdf996e1-fb32-4029-9d8c-1808473e72e7 61 fields · synced Jul 11, 2026
- FDA UDI 942e23c4-28a2-4289-8dd9-3d9104295562 32 fields · synced May 30, 2026
- EUDAMED 1902549a-756f-4974-8ae8-e394a6ffbaa7 61 fields · synced Jul 9, 2026
- EUDAMED c373f9ac-7602-4b5d-a253-c2648bdcd8fa 61 fields · synced Jul 10, 2026