Identity
- Trade Name
- INTEGRA 3 FDA UDI
- Generic Name
- Assisted reproduction electromechanical micromanipulator FDA UDI
- Device Name
- Assisted Reproduction Micromanipulator and Microinjector FDA UDI
- Model / Reference
- Integra 3 Thermosafe Leica DMi 1 x SAS, 1 x SAS-SE FDA UDI
- Description
- Assisted Reproduction Micromanipulator and Microinjector FDA UDI
Identifiers
- Catalog Number
- 6-54-100-11 FDA UDI
- Primary DI / UDI-DI
- 05060488042447 FDA UDI
- 510(k) Number
- K003142 FDA UDI
- FDA Product Code
- MQJ FDA UDI
- GMDN Term
- Assisted reproduction electromechanical micromanipulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6150 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: Assisted reproduction electromechanical micromanipulator
Integra 3 by Research Instruments , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K003142 also covers:
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
- INTEGRA 3 — Research Instruments , Ltd.
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
- Research Instruments , Ltd.
Sources (1)
- FDA UDI bd221a66-c873-4375-9120-203d389bbfca 36 fields · synced Jun 1, 2026