Identity
- Trade Name
- Medit Splints EUDAMEDFDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- Medit Splints EUDAMEDSW version: 1.1.x FDA UDI
- Model / Reference
- MA-ASP EUDAMEDMedit Splints FDA UDI
- Description
- SW version: 1.1.x FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800026700173 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000267MA-ASPA8 EUDAMED
- Direct Marketing DI
- 08800026700173 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z12119082 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CAD/CAM software
Medit Splints by Medit Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- ProPlan CMF — Materialise NV · Class I
- CEREC Guide — Sirona Dental Systems GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medit Corp.
Sources (2)
- FDA UDI 0d1719b5-5192-46d5-9cc1-0efda1231ec4 33 fields · synced Jul 31, 2026
- EUDAMED c5e375cb-0005-4e87-8e46-7ffef09c0a29 61 fields · synced Jul 31, 2026