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Micromanipulator System
EUDAMEDFDA UDIClass I (EU MDR)
Ref IMS-320U-SModel IMS-320D，IMS-320U，IMS-320D-S，IMS-320U-S
Identity
- Trade Name
- Micromanipulator System EUDAMEDHARIOMED FDA UDI
- Generic Name
- Assisted reproduction electromechanical micromanipulator FDA UDI
- Device Name
- Micromanipulator System EUDAMED
- Model / Reference
- IMS-320D，IMS-320U，IMS-320D-S，IMS-320U-S EUDAMEDIMS-320U-S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975183900055 EUDAMEDFDA UDI
- Basic UDI-DI
- 697518390IMS3202345R9 EUDAMED
- Direct Marketing DI
- 06975183900055 EUDAMED
- FDA Product Code
- MQJ FDA UDI
- EMDN Code
- U08020399 DEVICES FOR MICROMANIPULATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION - OTHER 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
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Micromanipulator System by Hua Yue Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697518390IMS3202345R9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hua Yue Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000037345
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 578bd16d-371b-4b28-9ac1-a84b3a4526cc 61 fields · synced Jul 9, 2026
- FDA UDI 1e1b1f21-9b1d-48a5-95ed-5ad9b378e003 32 fields · synced May 29, 2026