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Bmn2420
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref noneModel BP-B1Ref BMN2420
by B&L Biotech
Identity
- Trade Name
- BMN2420 EUDAMEDNeedle FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Beta Mini EUDAMED
- Model / Reference
- BP-B1 EUDAMEDnone EUDAMEDBMN2420 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019101598 EUDAMEDFDA UDI08800019101772 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191MINIMY EUDAMEDB-08800019101772 EUDAMED
- 510(k) Number
- K060347 FDA UDI
- 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
Yes
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
No
FDA UDIFDA 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
Bmn2420 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 | 88000191MINIMY | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000191MINIMY | 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 (5)
- EUDAMED 095b1c30-206b-4820-be34-2052fbe36703 61 fields · synced Jul 11, 2026
- EUDAMED 5499010a-91eb-4a54-9916-6cdc7b53e398 61 fields · synced May 18, 2026
- FDA UDI c0aff52f-6582-4dea-85c9-7948e79e25e3 33 fields · synced May 30, 2026
- FDA UDI e1c342d2-0adb-48d1-8c86-a10c6e9e3d43 32 fields · synced May 30, 2026
- EUDAMED d8a1f85f-66d6-4f49-9959-b8aead818e1a 61 fields · synced Jul 9, 2026