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SuperEndo-Beta
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref noneModel WL-B1
by B&L Biotech
Identity
- Trade Name
- SuperEndo-Beta EUDAMEDB&L-Beta(W) FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- SuperEndo-Beta EUDAMED
- Model / Reference
- WL-B1 EUDAMEDFDA UDInone EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019101635 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191BETAJZ EUDAMEDB-08800019101635 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-Beta 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 | 88000191BETAJZ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000191BETAJZ | 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 df370e77-447a-4321-8f6a-e7c1c9fa2362 61 fields · synced Jun 19, 2026
- EUDAMED d952f3ee-855f-43ea-a90d-b25a7161a8e0 61 fields · synced May 17, 2026
- FDA UDI 7e968bdf-8c97-4aa3-b88b-32d1e21211f7 32 fields · synced May 30, 2026