Identity
- Trade Name
- CER-2 Optima FDA UDI
- Generic Name
- Endoscope washer-disinfector (chemical) FDA UDI
- Device Name
- CER-2 Optima FDA UDI
- Model / Reference
- CER-2 Optima FDA UDI
- Description
- CER-2 Optima FDA UDI
Identifiers
- Catalog Number
- CER2OPTIMA FDA UDI
- Primary DI / UDI-DI
- 00677964052491 FDA UDI
- 510(k) Number
- K871712 FDA UDI
- FDA Product Code
- NVE FDA UDI
- GMDN Term
- Endoscope washer-disinfector (chemical) 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
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
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 washer-disinfector (chemical)
CER-2 Optima by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscope washer-disinfector (chemical).
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Cleared under the same submission
K871712 also covers:
- CER-1 — MEDIVATORS INC.
- CER-1 Optima — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
- Medivators Hookup — MEDIVATORS INC.
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
- Medivators Inc.
Sources (1)
- FDA UDI 1fdc3716-86a1-4892-a113-f8e8d8d75dce 36 fields · synced May 30, 2026