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SCANLAN® V.I.P™ instrument sterilization trays
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2146-03
Identity
- Trade Name
- SCANLAN® V.I.P™ Instrument Sterilization Trays FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- SCANLAN® V.I.P™ instrument sterilization trays EUDAMEDThoracoscopic VATS Sterilization Tray FDA UDI
- Model / Reference
- 2146-03 EUDAMEDFDA UDI
- Description
- Thoracoscopic VATS Sterilization Tray FDA UDI
Identifiers
- Catalog Number
- 2146-03 FDA UDI
- Primary DI / UDI-DI
- 00846159017892 EUDAMEDFDA UDI
- Basic UDI-DI
- 08461590TF06L9 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
SCANLAN® V.I.P™ instrument sterilization trays by Scanlan International Inc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Instrument tray, reusable.
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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 | 08461590TF06L9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scanlan International Inc.
- EUDAMED SRN
- US-MF-000010251
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 5e3697f0-64d3-47d4-8ad8-0b985839c37e 61 fields · synced Jul 30, 2026
- FDA UDI 3240c527-c85b-4819-9027-51fc3e2dad1e 35 fields · synced May 30, 2026