Identity
- Trade Name
- Mars 1800RE Workstation w/ RI Witness FDA UDI
- Generic Name
- Class-II biological safety cabinet FDA UDI
- Device Name
- IVF workstation with heat plate, 120V FDA UDI
- Model / Reference
- WM1800RE-W5120 FDA UDI
- Description
- IVF workstation with heat plate, 120V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937014570 FDA UDI
- FDA Product Code
- PUB FDA UDI
- GMDN Term
- Class-II biological safety cabinet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6120 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: Class-II biological safety cabinet
Mars 1800RE Workstation w/ RI Witness by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Class-II biological safety cabinet.
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- Mars 1800LE Workstation w/ RI Witness — CooperSurgical, Inc. · Class II
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 |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 914aa439-91b8-4956-9652-80d4e136e052 33 fields · synced Jun 9, 2026