Identity
- Trade Name
- RI SAS-SE Air Syringe EUDAMEDRI Syringe FDA UDI
- Generic Name
- Assisted reproduction electromechanical micromanipulator FDA UDI
- Device Name
- RI SAS-SE Air Syringe EUDAMEDAssisted Reproduction Micromanipulator and Microinjector FDA UDI
- Model / Reference
- 6-34-530 EUDAMEDAir Syringe - SAS SE FDA UDI
- Description
- Assisted Reproduction Micromanipulator and Microinjector FDA UDI
Identifiers
- Catalog Number
- 6-34-530 FDA UDI
- Primary DI / UDI-DI
- 05060170180044 EUDAMEDFDA UDI
- Basic UDI-DI
- 506055412TD005WK EUDAMED
- Direct Marketing DI
- 05060170180044 EUDAMED
- 510(k) Number
- K003142 FDA UDI
- FDA Product Code
- MQJ FDA UDI
- EMDN Code
- U08020380 DEVICES FOR MICROMANIPULATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION - ACCESSORIES EUDAMED
- GMDN Term
- Assisted reproduction electromechanical micromanipulator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6150 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Assisted reproduction electromechanical micromanipulator
RI Syringe by Research Instruments , Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 629a019c-3ac5-44d3-b6bf-aabf749b7b9b 36 fields · synced Jul 11, 2026
- EUDAMED feaea793-2257-41ee-a121-ff9a3b60d799 61 fields · synced Jul 11, 2026