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Chirurgie Box neu leer
EUDAMEDFDA UDIClass I (EU MDR)
Ref SDS00401Model SDS Chirurgie Tray
Identity
- Trade Name
- Chirurgie Box neu leer EUDAMEDSDS1.2/ SDS2.2 FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Surgical tray FDA UDI
- Model / Reference
- SDS Chirurgie Tray EUDAMEDSDS00401 EUDAMEDFDA UDI
- Description
- Surgical tray FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260468254063 EUDAMEDFDA UDI
- Basic UDI-DI
- 426046825TD02PG08CJ EUDAMED
- Direct Marketing DI
- 04260468254063 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Chirurgie Box neu leer by SDS Swiss Dental Solutions AG — 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 | 426046825TD02PG08CJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SDS Swiss Dental Solutions AG
- EUDAMED SRN
- CH-MF-000019073
- Authorised Representative
- SDS Deutschland GmbH DE-AR-000005774
Sources (2)
- EUDAMED 5ab45a87-ca38-426d-b96f-337101e73db6 61 fields · synced Oct 6, 2026
- FDA UDI 34395b08-8376-43e1-88be-81daa8a91946 34 fields · synced May 30, 2026