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Vibrapost
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref noneModel VPEModel VPA, VPE
by B&L Biotech
Identity
- Trade Name
- VIBRAPOST EUDAMEDFDA UDI
- Generic Name
- Root canal post kit FDA UDI
- Device Name
- VIBRAPOST EUDAMED
- Model / Reference
- VPE EUDAMEDFDA UDInone EUDAMEDVPA, VPE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019110293 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800019110293 EUDAMED88000191VPTIPRJ EUDAMED
- FDA Product Code
- JET FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Root canal post kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6650 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
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
Vibrapost by B&L Biotech — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800019110293 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800019110293 | 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 ca957eb1-7c37-456e-a707-cfc6fd8ad66c 61 fields · synced Sep 30, 2026
- EUDAMED f9228caf-f8e5-4871-bec7-556faaf48f2c 61 fields · synced May 18, 2026
- FDA UDI 834810a7-5c4b-403f-b658-7f93f4ffe8ea 32 fields · synced May 30, 2026
- EUDAMED f9228caf-f8e5-4871-bec7-556faaf48f2c-1 61 fields · synced Jun 9, 2026