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Sterile Disposable Endoscopic Forceps
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref JY-PK-350-18-S
Identity
- Trade Name
- Jiyuan FDA UDI
- Generic Name
- Rigid endoscopic biopsy forceps, single-use FDA UDI
- Device Name
- Sterile Disposable Endoscopic Forceps EUDAMEDFlat type, 350mm, diameter 1.8mm FDA UDI
- Model / Reference
- JY-PK-350-18-S EUDAMEDFDA UDI
- Description
- Flat type, 350mm, diameter 1.8mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973672290861 EUDAMED06973672290052 FDA UDI
- Basic UDI-DI
- 697367229001MB EUDAMED
- FDA Product Code
- HFB FDA UDI
- EMDN Code
- U0903010101 COLD BIOPSY FORCEPS FOR UROGENITAL ENDOSCOPY, SINGLE-USE EUDAMED
- GMDN Term
- Rigid endoscopic biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sterile Disposable Endoscopic Forceps by Jiangsu Jiyuan Medical Technology Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697367229001MB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Jiyuan Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018782
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 046326d6-2489-4f17-b1c9-3ebda7bb756b 61 fields · synced Jul 16, 2026
- FDA UDI 37a425d0-839b-4728-8622-d8dc88b0fc3f 34 fields · synced May 30, 2026