← Back to catalogue
Epoflier
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref A.4086Model BLUSCOPE MIDI SELF-LED-LIGHT
by Sapi Med Spa
Identity
- Trade Name
- EPO FLIER EUDAMEDEpoflier FDA UDI
- Generic Name
- Optical anoscope, single-use FDA UDI
- Device Name
- EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile. FDA UDI
- Model / Reference
- BLUSCOPE MIDI SELF-LED-LIGHT EUDAMEDA.4086 EUDAMEDSurgical retractor FDA UDI
- Description
- EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile. FDA UDI
Identifiers
- Catalog Number
- A.4086 FDA UDI
- Primary DI / UDI-DI
- 08033638801352 EUDAMEDFDA UDI
- Basic UDI-DI
- 803363880ANSCPSTPK 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Optical anoscope, single-use
Epoflier 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sapi Med Spa
Sources (2)
- FDA UDI 426b75c8-b4e0-495e-a9f3-3fcf43db19f3 35 fields · synced Jun 19, 2026
- EUDAMED f38ed15b-e36b-4914-850e-ac33e106b4ca 61 fields · synced Jun 19, 2026