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Smop
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 07649997938014Model SMOP Version 2, 2INGIS Version 2, CAMLOG Version 2, MSOFT Version 2
by Swissmeda AG
Identity
- Trade Name
- SMOP EUDAMEDSwissmeda Dental Planning System FDA UDI
- Generic Name
- Dental treatment application software FDA UDI
- Device Name
- Swissmeda Dental Planning System EUDAMEDSMOP Dental Planning System 2.21.0 FDA UDI
- Model / Reference
- SMOP Version 2, 2INGIS Version 2, CAMLOG Version 2, MSOFT Version 2 EUDAMED07649997938014 EUDAMED2.21.0 FDA UDI
- Description
- SMOP Dental Planning System 2.21.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07649997938014 EUDAMEDFDA UDI
- Basic UDI-DI
- 7649997938SDPSV2CV EUDAMED
- 510(k) Number
- K112251 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Dental treatment application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Smop by Swissmeda AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7649997938SDPSV2CV | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Swissmeda AG
- EUDAMED SRN
- CH-MF-000031883
- Authorised Representative
- TROPHY FR-AR-000001797
Sources (2)
- EUDAMED 674342e2-69c0-457a-bad6-27003743e606 61 fields · synced Jul 9, 2026
- FDA UDI abef5142-0c6c-4ad7-a37e-cd56e257d339 34 fields · synced May 30, 2026