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Como
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel VC3Model COMO, COMO W, COMO P, CT1, CT2, CT3, CT4, RD1, RD2, RD3, CD1, CD2, CD3, VC1, VC2, VC3, VC4Model COMO WModel CT1Model CD3Model RD1Model CD2Model CT4Model CT3
by B&L Biotech
Identity
- Trade Name
- COMO EUDAMEDCOMO Tip FDA UDICOMO White FDA UDI
- Generic Name
- Dental material application tool, reusable FDA UDI
- Device Name
- COMO EUDAMED
- Model / Reference
- VC3 EUDAMEDFDA UDInone EUDAMEDCOMO, COMO W, COMO P, CT1, CT2, CT3, CT4, RD1, RD2, RD3, CD1, CD2, CD3, VC1, VC2, VC3, VC4 EUDAMEDCOMO W EUDAMEDCT1 EUDAMEDFDA UDICD3 EUDAMEDFDA UDIRD1 EUDAMEDFDA UDICD2 EUDAMEDFDA UDICT4 EUDAMEDFDA UDICT3 EUDAMEDFDA UDICOMW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019111344 EUDAMEDFDA UDI08800019110774 EUDAMEDFDA UDI08800019110743 EUDAMEDFDA UDI08800019110729 EUDAMEDFDA UDI08800019111290 EUDAMEDFDA UDI08800019111276 EUDAMEDFDA UDI08800019111283 EUDAMEDFDA UDI08800019110767 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800019111344 EUDAMED88000191COMOLZ EUDAMEDB-08800019110729 EUDAMEDB-08800019110743 EUDAMEDB-08800019111283 EUDAMEDB-08800019111290 EUDAMEDB-08800019111276 EUDAMEDB-08800019110774 EUDAMEDB-08800019110767 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 UDIFDA UDI
Serial Number
No
FDA UDIFDA 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-08800019111344 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800019111344 | 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 (31)
- EUDAMED 341fbb45-00ea-42ce-bac7-9bc034be0089 61 fields · synced Sep 18, 2026
- EUDAMED d56d73cd-c865-41a0-a1b5-11ac8a746e2e 61 fields · synced May 11, 2026
- EUDAMED 283db9f7-64e4-484c-b58e-8521a55a11bc 61 fields · synced May 16, 2026
- EUDAMED 6709342e-b4fc-4a97-9bfb-59e3d90f583a 61 fields · synced May 16, 2026
- EUDAMED c691dda6-826c-4e5a-9c32-cf1d1a95059f 61 fields · synced May 16, 2026
- EUDAMED beeffcbe-e801-4288-8ce6-7bfc43893268 61 fields · synced May 16, 2026
- EUDAMED fdb3ef53-39eb-4bf5-b561-bd623229085e 61 fields · synced May 17, 2026
- EUDAMED d1191ecc-a15d-436e-9846-1b445b0452f5 61 fields · synced May 18, 2026
- EUDAMED 32020d98-67e2-430b-b7b8-71b3c3f35509 61 fields · synced May 18, 2026
- EUDAMED 044d3df9-47a8-4629-89d1-42113ea6b96b 61 fields · synced May 18, 2026
- EUDAMED a60d4f7d-0f0e-4322-b0eb-1cc0cf40cfe2 61 fields · synced May 18, 2026
- EUDAMED 801ae666-4b1d-4686-a215-16b8bc8f974b 61 fields · synced May 18, 2026
- EUDAMED d3486d34-1af5-47d2-a14f-76f160cb8d0c 61 fields · synced May 18, 2026
- EUDAMED 59f2c540-c2f8-455e-9b55-eb2d2472063e 61 fields · synced May 18, 2026
- EUDAMED 188c8717-8150-4d1e-a007-8ada2a39f708 61 fields · synced May 19, 2026
- EUDAMED 980f9d11-5d9f-4e9d-acb4-500af201b878 61 fields · synced May 19, 2026
- FDA UDI 67cadaaa-6327-4975-8487-6f68750c82d6 32 fields · synced May 29, 2026
- FDA UDI 80eea35c-bf46-42ed-b83f-b1de6f42b9c3 32 fields · synced May 30, 2026
- FDA UDI 90527f8c-38f4-4718-98cf-a12a7e568ae2 32 fields · synced May 30, 2026
- FDA UDI 115667f0-9fa9-4953-b704-d8dfc378ba99 32 fields · synced May 30, 2026
- FDA UDI 522a3a2a-97de-485a-a375-c4a951430492 32 fields · synced May 30, 2026
- FDA UDI e6012590-550e-4e6a-a6a9-6671282e0d27 32 fields · synced May 30, 2026
- FDA UDI 1fa662fd-00f8-4e65-bfcc-2715ef3a5ede 32 fields · synced May 30, 2026
- FDA UDI 648c44f5-cf3c-4e79-b17d-38ce88f36bc0 32 fields · synced May 30, 2026
- EUDAMED fdb3ef53-39eb-4bf5-b561-bd623229085e-1 61 fields · synced Jul 11, 2026
- EUDAMED d3486d34-1af5-47d2-a14f-76f160cb8d0c-1 61 fields · synced Jul 11, 2026
- EUDAMED 044d3df9-47a8-4629-89d1-42113ea6b96b-1 61 fields · synced Jul 12, 2026
- EUDAMED beeffcbe-e801-4288-8ce6-7bfc43893268-1 61 fields · synced Jul 16, 2026
- EUDAMED 32020d98-67e2-430b-b7b8-71b3c3f35509-1 61 fields · synced Jul 29, 2026
- EUDAMED 6709342e-b4fc-4a97-9bfb-59e3d90f583a-1 61 fields · synced Aug 1, 2026
- EUDAMED 283db9f7-64e4-484c-b58e-8521a55a11bc-1 61 fields · synced Aug 2, 2026