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Como
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel VC4Model COMO, COMO W, COMO P, CT1, CT2, CT3, CT4, RD1, RD2, RD3, CD1, CD2, CD3, VC1, VC2, VC3, VC4
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
- VC4 EUDAMEDFDA UDInone EUDAMEDCOMO, COMO W, COMO P, CT1, CT2, CT3, CT4, RD1, RD2, RD3, CD1, CD2, CD3, VC1, VC2, VC3, VC4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019111351 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800019111351 EUDAMED88000191COMOLZ 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 — 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-08800019111351 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800019111351 | 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 c5b9a858-f566-4505-b8db-15599f680f4e 61 fields · synced Jul 10, 2026
- EUDAMED 69d08eac-e29a-4273-b641-e50debf2acc6 61 fields · synced May 18, 2026
- FDA UDI 2b5154de-3982-412a-b859-78599fe7c0d2 32 fields · synced May 30, 2026