Identity
- Trade Name
- Spotter EUDAMEDSpotter Device (without accessories) FDA UDI
- Generic Name
- Magnetic metal detector FDA UDI
- Device Name
- Spotter EUDAMEDSpotter Device (without accessories) FDA UDI
- Model / Reference
- Spotter EUDAMED5-SPR-000 EUDAMEDSPR FDA UDI
- Description
- Spotter Device (without accessories) FDA UDI
Identifiers
- Catalog Number
- 5-SPR-000 FDA UDI
- Primary DI / UDI-DI
- 07290114352000 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290114352009Q EUDAMED
- Direct Marketing DI
- 07290114352000 EUDAMED
- FDA Product Code
- LNF FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Magnetic metal detector FDA UDI
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Spotter by Forum Engineering Technologies (96) 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 | 7290114352009Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Forum Engineering Technologies (96) Ltd.
- EUDAMED SRN
- IL-MF-000023254
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 4aec2add-4404-4dc6-91e6-130b02c1ef4b 61 fields · synced Jun 6, 2026
- FDA UDI 203d343d-f410-4dd5-b0cd-77a0d62c6caa 34 fields · synced May 30, 2026