Identity
- Trade Name
- Scan-Mate® (Blue) FDA UDI
- Generic Name
- Hand-held dental retractor FDA UDI
- Device Name
- Scan-Mate® (Black) EUDAMED1 FDA UDI
- Model / Reference
- 40100 EUDAMED40101 EUDAMEDFDA UDI
- Description
- 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009411920 EUDAMEDFDA UDI
- Basic UDI-DI
- 008600SCMAT4B EUDAMED
- Direct Marketing DI
- 00860009411920 EUDAMED
- FDA Product Code
- EIF FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Hand-held dental retractor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Scan-Mate® (Black) by Armor Dental Corp. — 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 | 008600SCMAT4B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Armor Dental Corp
- EUDAMED SRN
- US-MF-000032924
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED 8be1d199-ab90-42f9-be40-9975f6bd5978 61 fields · synced Jun 18, 2026
- FDA UDI 1bee168d-e908-4db0-b2ab-6bfcaf9b459e 33 fields · synced May 25, 2026