Identity
- Trade Name
- VAROGuide PreGuide FDA UDI
- Generic Name
- Dental guided surgery reference plate FDA UDI
- Device Name
- VAROGuide PreGuide EUDAMED
- Model / Reference
- VAROGuide PreGuide PGA EUDAMEDPGA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800038700048 EUDAMEDFDA UDI
- Basic UDI-DI
- 880003870017B5 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental guided surgery reference plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Poland 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
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 UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
VAROGuide PreGuide by Dms Co., Ltd. — 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 | 880003870017B5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dms Co., Ltd.
- EUDAMED SRN
- KR-MF-000016967
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (2)
- EUDAMED 911b68d9-aee6-4b33-9fb1-4b7886c08c26 61 fields · synced Jul 20, 2026
- FDA UDI 6c34dc7c-dd11-4f9f-bdb4-d2eea604aa76 32 fields · synced May 29, 2026