Identity
- Trade Name
- Pen-LED-Light EUDAMEDPen LED FDA UDI
- Generic Name
- Endoscopic light source unit, battery-powered FDA UDI
- Device Name
- Light Generators Line EUDAMEDPen-LED-light for Sapi Med anoscopes, rectoscopes and retractors. FDA UDI
- Model / Reference
- B.0306 EUDAMEDPen LED light FDA UDI
- Description
- Pen-LED-light for Sapi Med anoscopes, rectoscopes and retractors. FDA UDI
Identifiers
- Catalog Number
- B.0306 FDA UDI
- Primary DI / UDI-DI
- 08033638801048 EUDAMEDFDA UDI
- Basic UDI-DI
- 803363880CLDLGHTJ7 EUDAMED
- FDA Product Code
- NTN FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Endoscopic light source unit, battery-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic light source unit, battery-powered
Pen LED by Sapi Med Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sapi Med Spa
Sources (2)
- FDA UDI 180b9d05-2b10-4a8d-873e-18d03353f1d8 34 fields · synced Jul 13, 2026
- EUDAMED 4ba7725a-5791-4ef0-9ccc-413717bda14a 61 fields · synced Jul 13, 2026