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Vf-20
EUDAMEDFDA UDIClass I (EU MDR)
Ref VF-20
by Jessop Precision Products, Inc (Trading as The Suremark Company)
Identity
- Trade Name
- VF-20 EUDAMEDDentalMark FDA UDI
- Generic Name
- Dental guided surgery registration/navigation spatial marker FDA UDI
- Device Name
- DM SERIES EUDAMED
- Model / Reference
- VF-20 EUDAMEDDentalMark 2.0mm Visionline ball on denture sized label FDA UDI
Identifiers
- Primary DI / UDI-DI
- B971VF201 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B971DentalMark8N EUDAMED
- FDA Product Code
- JAC FDA UDI
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
- GMDN Term
- Dental guided surgery registration/navigation spatial marker FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1640 FDA UDI
- Market of Registration
- France 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
Yes
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
Vf-20 by Jessop Precision Products, Inc (Trading as The Suremark Company) — 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 | ++B971DentalMark8N | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- EUDAMED SRN
- US-MF-000013348
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (2)
- EUDAMED 1ce41bdf-7dd0-4bb3-801e-2986af86fb62 61 fields · synced Oct 7, 2026
- FDA UDI 9aab3088-6844-40f5-859d-c8b05196aa15 33 fields · synced May 24, 2026