Rectoscope
FDA UDIEUDAMEDClass II (US FDA UDI)
by Sapi Med Spa
Identity
- Trade Name
- MPR - Multi Purpose Rectoscope EUDAMEDRectoscope FDA UDI
- Generic Name
- Optical proctoscope, single-use FDA UDI
- Device Name
- Multi-purpose rectoscope FDA UDI
- Model / Reference
- A.4522 EUDAMEDFDA UDIProctoscope EUDAMED
- Description
- Multi-purpose rectoscope FDA UDI
Identifiers
- Catalog Number
- A.4522 FDA UDI
- Primary DI / UDI-DI
- 08033638800263 EUDAMEDFDA UDI
- Basic UDI-DI
- 803363880RCTSCSTVX EUDAMED
- 510(k) Number
- K070915 FDA UDI
- FDA Product Code
- KDM FDA UDI
- EMDN Code
- G02060301 ANOSCOPES EUDAMED
- GMDN Term
- Optical proctoscope, 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
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
Yes
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
No
Manufacturing Date
Yes
Category: Optical proctoscope, single-use
Rectoscope by Sapi Med Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K070915 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 |
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Manufacturer
- Manufacturer
- Sapi Med Spa
Sources (2)
- FDA UDI c3a974ee-6a27-4084-b85e-cf32cdd34817 35 fields · synced Jun 20, 2026
- EUDAMED 009db8cf-1197-4c47-8655-0698ef2e44ee 61 fields · synced Jun 20, 2026