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Cylinder Screw
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref CS200Model IH IMPLANT SYSTEM Ref CS300
Identity
- Trade Name
- Cylinder Screw EUDAMEDIH Multi-unit CCM Cylinder Screw FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Cylinder Screw EUDAMEDSEWON MEDIX IH Multi-unit CCM Cylinder Screw Hex Non-Coating, Ø1.35x3.5x1.4mm FDA UDI
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDCS200 EUDAMEDFDA UDICS300 EUDAMED
- Description
- SEWON MEDIX IH Multi-unit CCM Cylinder Screw Hex Non-Coating, Ø1.35x3.5x1.4mm FDA UDI
Identifiers
- Catalog Number
- CS200 FDA UDI
- Primary DI / UDI-DI
- 08800041356140 EUDAMEDFDA UDI08800041356157 EUDAMED
- Basic UDI-DI
- B-08800041356140 EUDAMEDB-08800041356157 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 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
Yes
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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cylinder Screw by SEWONMEDIX Inc. — Class IIb — 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-08800041356140 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 1ef7bcd3-1f25-4d83-b1d4-043a08f85fe1 61 fields · synced Jul 9, 2026
- EUDAMED acb2a7d3-6258-438a-9c26-1c57a734dd4a 61 fields · synced May 19, 2026
- FDA UDI eeebd636-1733-43fe-8392-c132992628d1 34 fields · synced May 30, 2026