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Como
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel COMO, COMO W, COMO P, CT1, CT2, CT3, CT4, RD1, RD2, RD3, CD1, CD2, CD3, VC1, VC2, VC3, VC4Model RD3
by B&L Biotech
Identity
- Trade Name
- COMO EUDAMEDCOMO Tip FDA UDI
- Generic Name
- Dental material application tool, reusable FDA UDI
- Device Name
- COMO EUDAMED
- Model / Reference
- COMO, COMO W, COMO P, CT1, CT2, CT3, CT4, RD1, RD2, RD3, CD1, CD2, CD3, VC1, VC2, VC3, VC4 EUDAMEDnone EUDAMEDRD3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019111313 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191COMOLZ EUDAMEDB-08800019111313 EUDAMED
- FDA Product Code
- KXR FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material application tool, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3140 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
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
Como by B&L Biotech — Class I — 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 | 88000191COMOLZ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 88000191COMOLZ | 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 (3)
- EUDAMED d5c8940c-162b-4fd6-9594-466dedadfaf3 61 fields · synced Jun 9, 2026
- EUDAMED 8aed0ffb-76e2-4ad3-99e2-734eadab39ce 61 fields · synced May 17, 2026
- FDA UDI e879deca-e1bf-4e0f-961f-51a4dea95c7c 32 fields · synced May 30, 2026