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BL-B Kondenser
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel BL-B Kondenser 35/70, BL-B Kondenser 35/70-L, BL-B Kondenser 40/80, BL-B Kondenser 40/80-L, BL-B Kondenser 50/100, BL-B Kondenser 50/100-L, BL-B Kondenser 60/120, BL-B Kondenser 60/120-L, BL-B Kondenser Set, BL-B Kondenser Set-LModel BL-B Kondenser 60/120
by B&L Biotech
Identity
- Trade Name
- BL-B Kondenser EUDAMEDBL-B Kondenser 60/120 FDA UDI
- Generic Name
- Endodontic plugger FDA UDI
- Device Name
- BL-B Kondenser EUDAMED
- Model / Reference
- BL-B Kondenser 35/70, BL-B Kondenser 35/70-L, BL-B Kondenser 40/80, BL-B Kondenser 40/80-L, BL-B Kondenser 50/100, BL-B Kondenser 50/100-L, BL-B Kondenser 60/120, BL-B Kondenser 60/120-L, BL-B Kondenser Set, BL-B Kondenser Set-L EUDAMEDnone EUDAMEDBL-B Kondenser 60/120 EUDAMEDBKX60 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019110132 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191BKONLA EUDAMEDB-08800019110132 EUDAMED
- FDA Product Code
- EKG FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic plugger FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Yes
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
BL-B Kondenser by B&L Biotech — Class I — 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 | 88000191BKONLA | Class I | Active |
| EUDAMED | European Union | CE/MDD | 88000191BKONLA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 5d8280a2-bcdd-4ef6-bf60-70b598985917 61 fields · synced Jun 18, 2026
- EUDAMED ff1c3411-2c30-41b0-a941-a1fdc38e08c8 61 fields · synced May 17, 2026
- FDA UDI ed004085-f032-4755-99eb-7ef5e54a86e2 32 fields · synced May 30, 2026
- EUDAMED 5d8280a2-bcdd-4ef6-bf60-70b598985917-1 61 fields · synced Jun 9, 2026