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BIOM Optic Set disposable, with BIOM HD Professional lens for f=200 mm
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- BIOM Optic Set disposable, with BIOM HD Professional lens for f=200 mm FDA UDI
- Generic Name
- Ophthalmic surgical microscope FDA UDI
- Device Name
- BIOM Optic Set disposable, with BIOM HD Professional lens for f=200 mm FDA UDI
- Model / Reference
- 54412 FDA UDI
- Description
- BIOM Optic Set disposable, with BIOM HD Professional lens for f=200 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584024077 FDA UDI
- FDA Product Code
- HOH FDA UDI
- GMDN Term
- Ophthalmic surgical microscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic surgical microscope
BIOM Optic Set disposable, with BIOM HD Professional lens for f=200 mm by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — Class I — FDA UDI…
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 0244777b-8e91-456f-a657-785d3db54f54 34 fields · synced Jun 1, 2026