Identity
- Trade Name
- HD 3CMOS CAMERA HEAD FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- HD 3CMOS CAMERA HEAD FDA UDI
- Model / Reference
- OLYMPUS CH-S200-XZ-EB FDA UDI
- Description
- HD 3CMOS CAMERA HEAD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170379611 FDA UDI
- 510(k) Number
- K200542 FDA UDI
- FDA Product Code
- OWN FDA UDIFET FDA UDINWB FDA UDI
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope video camera
Hd 3cmos Camera Head by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200542 also covers:
- HD 3CMOS AUTOCLAVABLE CAMERA HEAD — Olympus Medical Systems Corporation
- VISERA ELITE II VIDEO SYSTEM CENTER — Olympus Medical Systems Corporation
- VISERA ELITE II XENON LIGHT SOURCE — Olympus Medical Systems Corporation
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
- Olympus — Olympus Winter & Ibe GmbH
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI a5c35a11-f6b5-440f-b9c0-295ad292b4fb 35 fields · synced Jun 8, 2026