Self-light anoscopes
FDA UDIEUDAMEDClass II (US FDA UDI)
by Sapi Med Spa
Identity
- Trade Name
- SELF-LED-LIGHT EUDAMEDSelf-light anoscopes FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- SELF-LED-LIGHT - Surgical/Examination flute beaked proctoscope with built-in LED light. Disposable. Tube length 88mm. Tube diameter 23mm. FDA UDI
- Model / Reference
- Proctoscope EUDAMEDA.4023.1L EUDAMEDOperative Self-Led-Light FDA UDI
- Description
- SELF-LED-LIGHT - Surgical/Examination flute beaked proctoscope with built-in LED light. Disposable. Tube length 88mm. Tube diameter 23mm. FDA UDI
Identifiers
- Catalog Number
- A.4023.1L FDA UDI
- Primary DI / UDI-DI
- 08033638800478 EUDAMEDFDA UDI
- Basic UDI-DI
- 803363880ANSCPB6 EUDAMED
- 510(k) Number
- K070913 FDA UDI
- FDA Product Code
- FER FDA UDI
- EMDN Code
- G02060301 ANOSCOPES EUDAMED
- GMDN Term
- Optical anoscope, single-use 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Optical anoscope, single-use
Self-light anoscopes by Sapi Med Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Optical anoscope, single-use.
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope — THD SPA · Class II
- HEINE UniSpec® Disposable Tubes — Heine Optotechnik GmbH & Co. KG · Class II
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope — THD SPA · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope — THD SPA · Class II
- ANOSPEC — OBP CORPORATION · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope — THD SPA · Class II
Cleared under the same submission
K070913 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sapi Med Spa
Sources (2)
- FDA UDI 30152e0d-01d4-4c91-9b7e-8adfced99371 35 fields · synced Jun 19, 2026
- EUDAMED edf31807-fd2c-43c4-9fe8-43c781a170c2 61 fields · synced Jun 19, 2026