IVF Workstation
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- IVF Workstation EUDAMEDHARIOMED FDA UDI
- Generic Name
- Class-II biological safety cabinet FDA UDI
- Device Name
- IVF Workstation EUDAMED
- Model / Reference
- IW-A1800，IW-A1800S，IW-A1800M，IW-A1800D，IW-A950，IW-A1350A，IW-A1350C，IW-A1350S EUDAMEDIW-A1800 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975183900109 EUDAMEDFDA UDI
- Basic UDI-DI
- 697518390IWA012345674R EUDAMED
- Direct Marketing DI
- 06975183900109 EUDAMED
- FDA Product Code
- QKH FDA UDI
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMED
- GMDN Term
- Class-II biological safety cabinet FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Market of Registration
- Türkiye 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Assisted reproduction vitrification carrier
IVF Workstation by Hua Yue Medical Technology Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697518390IWA012345674R | 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 ad9b2f72-c706-4e02-ace6-17415f9c4b20 61 fields · synced Jul 20, 2026
- FDA UDI 017ca51b-59c2-4004-afe5-e1a482f906cf 32 fields · synced May 29, 2026