Camera Coupler, T-Mount To Sony "e" Mount
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- CAMERA COUPLER, T-MOUNT TO SONY "E" MOUNT EUDAMEDFDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Model / Reference
- M 528XSLR-NEX EUDAMEDFDA UDIGlobal Surgical Operating Microscope System EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810040251009 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004025GSOMSWD EUDAMED
- FDA Product Code
- EPT FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- General-purpose surgical microscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4700 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose surgical microscope
Camera Coupler, T-Mount To Sony "e" Mount by Global Surgical Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as General-purpose surgical microscope.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Global Surgical Corp.
Sources (2)
- FDA UDI 33cdbf40-4bfd-4c22-8802-f6581a6d3d94 32 fields · synced Sep 30, 2026
- EUDAMED 62d7c5e7-af6e-474a-84b6-099706a758a9 61 fields · synced Sep 30, 2026