← Back to catalogue
BL-S Kondenser
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel BL-S Kondenser 50/100-LModel BL-S Kondenser 60/120, BL-S Kondenser 60/120-L, BL-S Kondenser 35/70, BL-S Kondenser 35/70-L, BL-S Kondenser 50/100, BL-S Kondenser 50/100-L, BL-S Kondenser 40/80, BL-S Kondenser 40/80-L, BL-S Kondenser Set-L, BL-S Kondenser Set
by B&L Biotech
Identity
- Trade Name
- BL-S Kondenser EUDAMEDBL-S Kondenser 50/100-L FDA UDI
- Generic Name
- Endodontic plugger FDA UDI
- Device Name
- BL-S Kondenser EUDAMED
- Model / Reference
- BL-S Kondenser 50/100-L EUDAMEDnone EUDAMEDBL-S Kondenser 60/120, BL-S Kondenser 60/120-L, BL-S Kondenser 35/70, BL-S Kondenser 35/70-L, BL-S Kondenser 50/100, BL-S Kondenser 50/100-L, BL-S Kondenser 40/80, BL-S Kondenser 40/80-L, BL-S Kondenser Set-L, BL-S Kondenser Set EUDAMEDBCON50L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019110071 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800019110071 EUDAMED88000191SKONPZ EUDAMED
- FDA Product Code
- EKR 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-S 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 | B-08800019110071 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800019110071 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B&L Biotech
- EUDAMED SRN
- KR-MF-000023296
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED f3730dc4-b552-43de-9198-c38e814a95be 61 fields · synced Jul 22, 2026
- EUDAMED 2b166706-6479-47d3-be68-d6bae3af4b2a 61 fields · synced May 19, 2026
- FDA UDI 2e8e0a48-1cc0-4f35-ac54-37634be13fc1 32 fields · synced May 26, 2026
- EUDAMED 2b166706-6479-47d3-be68-d6bae3af4b2a-1 61 fields · synced Jun 10, 2026