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Revax M2 Space Maintainer 10 Pcs
EUDAMEDFDA UDIClass I (EU MDR)
Ref RE 0096
by Alphadent NV
Identity
- Trade Name
- REVAX M2 SPACE MAINTAINER 10 PCS EUDAMEDCEKA & PRECI-LINE ATTACHMENTS FDA UDI
- Generic Name
- Dental precision attachment fitting/adjustment tool FDA UDI
- Device Name
- CEKA REVAX M2 SPACE MAINTAINER EUDAMEDREVAX M2 SPACE MAINTAINER 10 PCS FDA UDI
- Model / Reference
- RE 0096 EUDAMEDFDA UDI
- Description
- REVAX M2 SPACE MAINTAINER 10 PCS FDA UDI
Identifiers
- Catalog Number
- RE 0096 FDA UDI
- Primary DI / UDI-DI
- 14260576943863 EUDAMEDFDA UDI
- Basic UDI-DI
- 426057694RE00964K EUDAMED
- Direct Marketing DI
- 14260576943863 EUDAMED
- FDA Product Code
- EGG FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental precision attachment fitting/adjustment tool FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3165 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Height — 0.3 Millimeter FDA UDI
Revax M2 Space Maintainer 10 Pcs by Alphadent NV — Class I — 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 | 426057694RE00964K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alphadent NV
- EUDAMED SRN
- BE-MF-000000923
Sources (2)
- EUDAMED 2b2fdaf0-bc8d-4f85-b71e-d4d0d8e10a24 61 fields · synced Aug 4, 2026
- FDA UDI 57e52ce2-eb43-4ef2-86fa-271dc7a629f5 36 fields · synced May 29, 2026