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IVF Workstation
EUDAMEDFDA UDIClass I (EU MDR)
Ref IW-A1800DModel IW-A1800，IW-A1800S，IW-A1800M，IW-A1800D，IW-A950，IW-A1350A，IW-A1350C，IW-A1350S
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-A1800D EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975183900130 EUDAMEDFDA UDI
- Basic UDI-DI
- 697518390IWA012345674R EUDAMED
- Direct Marketing DI
- 06975183900130 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
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
IVF Workstation 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 | 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 6332dc8c-573e-41f1-afb2-8221b04f9907 61 fields · synced Jul 25, 2026
- FDA UDI 0960deb0-0102-4e78-a34e-583ed52176d6 32 fields · synced May 30, 2026