Identity
- Trade Name
- RI SOS Oil Syringe EUDAMEDRI Syringe FDA UDI
- Generic Name
- Assisted reproduction electromechanical micromanipulator FDA UDI
- Device Name
- RI SOS Oil Syringe EUDAMEDAssisted Reproduction Micromanipulator and Microinjector FDA UDI
- Model / Reference
- 6-34-700 EUDAMEDOil Syringe - SOS FDA UDI
- Description
- Assisted Reproduction Micromanipulator and Microinjector FDA UDI
Identifiers
- Catalog Number
- 6-34-700 FDA UDI
- Primary DI / UDI-DI
- 05060170180051 EUDAMEDFDA UDI
- Basic UDI-DI
- 506017018TD005UF EUDAMED
- Direct Marketing DI
- 05060170180051 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
Similar devices
Also classified as Assisted reproduction electromechanical micromanipulator.
- MMO-202NDVM — NARISHIGE LIFEMED CO., LTD. · Class II
- IM-HD1TVM — NARISHIGE LIFEMED CO., LTD. · Class II
- IM-11-2VM — NARISHIGE LIFEMED CO., LTD. · Class II
- NTXVM-N3 — NARISHIGE LIFEMED CO., LTD. · Class II
- MTK-1VM-O2 — NARISHIGE LIFEMED CO., LTD. · Class II
- NT-88-V3VM 120V — NARISHIGE LIFEMED CO., LTD. · Class II
- MTK-1VM-N4 — NARISHIGE LIFEMED CO., LTD. · Class II
- ON3-99D-2VM 120V — NARISHIGE LIFEMED CO., LTD. · Class II
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 f8455488-bdf4-4302-bcab-59b5761a817a 36 fields · synced Jul 23, 2026
- EUDAMED c10a3fcb-1c54-4cbf-9573-4f7eeb43371c 61 fields · synced Jul 23, 2026