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SCANLAN® V.I.P™ instrument sterilization trays
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3303-04
Identity
- Trade Name
- SCANLAN® V.I.P.™ Sterilization Tray FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- SCANLAN® V.I.P™ instrument sterilization trays EUDAMEDReplacement mat for SCANLAN® Tray #2133-03 FDA UDI
- Model / Reference
- 3303-04 EUDAMEDFDA UDI
- Description
- Replacement mat for SCANLAN® Tray #2133-03 FDA UDI
Identifiers
- Catalog Number
- 3303-04 FDA UDI
- Primary DI / UDI-DI
- 00846159032505 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 40627248-dfe2-4ef1-b1fe-ee245c904790 61 fields · synced May 30, 2026
- FDA UDI 36ada56d-71bd-4004-a9d4-f26f32a922c3 35 fields · synced May 30, 2026