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SuperEndo-Alpha II
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref noneModel CL-A1
by B&L Biotech
Identity
- Trade Name
- SuperEndo-Alpha II EUDAMEDB&L-Alpha II(W) FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- SuperEndo-Alpha II EUDAMED
- Model / Reference
- CL-A1 EUDAMEDFDA UDInone EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019100010 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191ALPHAFS EUDAMEDB-08800019100010 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
- Poland 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SuperEndo-Alpha II 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 (3)
- EUDAMED 2198b797-ba90-40b6-9233-8a634c43edcf 61 fields · synced Jul 10, 2026
- EUDAMED ffc76cd2-e46b-4b39-a932-f79246d7ed50 61 fields · synced May 19, 2026
- FDA UDI d2949fad-0295-41af-9ddd-80f05c04961e 32 fields · synced May 30, 2026