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Scoop Stretcher
EUDAMEDFDA UDIClass I (EU MDR)
Ref YDC-4BModel YDC-4A,YDC-4A02,YDC-4B,YDC-4B02,YDC-4C,YDC-4D，YDC-4E
Identity
- Trade Name
- RED LEAF FDA UDI
- Generic Name
- Spine board FDA UDI
- Device Name
- Scoop Stretcher EUDAMED
- Model / Reference
- YDC-4A,YDC-4A02,YDC-4B,YDC-4B02,YDC-4C,YDC-4D，YDC-4E EUDAMEDYDC-4B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974442054133 EUDAMEDFDA UDI
- Basic UDI-DI
- 697444205SS001H5 EUDAMED
- FDA Product Code
- FPP FDA UDI
- EMDN Code
- V08050199 PATIENT TRANSFER STRETCHERS - OTHER EUDAMED
- GMDN Term
- Spine board FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6900 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Scoop Stretcher by Jiangsu Rixin Medical Equipment 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 | 697444205SS001H5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jiangsu Rixin Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000008761
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 1a118f08-e8af-430f-ad4e-2e5e3dc546d4 61 fields · synced Aug 3, 2026
- FDA UDI 2065356d-478e-4f82-aad4-ad64e423b222 32 fields · synced May 30, 2026