Identity
- Trade Name
- TomoSPOT FDA UDI
- Generic Name
- Radiological image marker, noninvasive, single-use FDA UDI
- Device Name
- TomoSPOT EUDAMEDMole Markers, low-density see-through ring, pinch-free material FDA UDI
- Model / Reference
- 782 EUDAMEDFDA UDI
- Description
- Mole Markers, low-density see-through ring, pinch-free material FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815137020490 EUDAMEDFDA UDI
- Basic UDI-DI
- 00815137020490BP EUDAMED
- Unit of Use DI
- 10815137020497 EUDAMED
- FDA Product Code
- JAC FDA UDI
- EMDN Code
- Z11030585 RADIOLOGY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Radiological image marker, noninvasive, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1640 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
TomoSPOT by Beekley Corporation — 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 | 00815137020490BP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Beekley Corporation
- EUDAMED SRN
- US-MF-000007055
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7d02e0dd-2a6a-47fb-8a68-2a7d8f737a39 61 fields · synced Aug 1, 2026
- FDA UDI 919bfabb-7c6f-447a-b05c-c3c121824824 33 fields · synced May 30, 2026