Identity
- Trade Name
- Surgical Microscope MM80/YOH FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Model / Reference
- MM80/YOH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04589698450268 FDA UDI
- FDA Product Code
- EPT FDA UDI
- GMDN Term
- General-purpose surgical microscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose surgical microscopeENT surgical microscopeNeurosurgical microscopeSurgical microscope fluorescent angiography system
Surgical Microscope MM80/YOH by Mitaka Kohki Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Microscope objective.
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- Surgical Microscope MM90/SS1 — MITAKA KOHKI CO., LTD. · Class I
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- Surgical Microscope MM80/SOH — MITAKA KOHKI CO., LTD. · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mitaka Kohki Co., Ltd.
Sources (2)
- FDA UDI 3b945d71-4ef3-4295-a852-bc1321155956 32 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026