Identity
- Trade Name
- SU-2100 FDA UDI
- Generic Name
- Radiological general body-part positioner FDA UDI
- Device Name
- SU-2100 EUDAMED
- Model / Reference
- N/A EUDAMEDSU-2100_V1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809832900111 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809832900111 EUDAMED
- FDA Product Code
- IXY FDA UDI
- EMDN Code
- Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological general body-part positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1880 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Su-2100 by Shinyoung For M Co., Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809832900111 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SHINYOUNG FOR M Co., Ltd.
- EUDAMED SRN
- KR-MF-000043632
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 8918e3eb-ad4c-49f8-83df-1afcf0026433 61 fields · synced Jul 12, 2026
- FDA UDI 0dd58936-c5c8-41db-853e-5f1e7c2b3c96 32 fields · synced May 30, 2026