Identity
- Trade Name
- Sterilization tray 7mm - 10 mm EUDAMEDSterilization tray FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Sterilization tray EUDAMEDTray supplied with the set containing the above-mentioned instruments, fixed by silicon fasteners. The tray is used to transport, store and sterilize the set of surgical instruments. FDA UDI
- Model / Reference
- ATMWCIN52 EUDAMED21 FDA UDI
- Description
- Tray supplied with the set containing the above-mentioned instruments, fixed by silicon fasteners. The tray is used to transport, store and sterilize the set of surgical instruments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437019739317 EUDAMEDFDA UDI
- Basic UDI-DI
- 8437019739ATMWCIN522L EUDAMED
- Direct Marketing DI
- 08437019739317 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Spain 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
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
Category: Instrument tray, reusable
Sterilization tray 7mm - 10 mm by Abanza Tecnomed, S.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 8437019739ATMWCIN522L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Abanza Tecnomed, S.l.
- EUDAMED SRN
- ES-MF-000007530
Sources (2)
- EUDAMED fcf9dee7-ca9c-4024-9558-180a92207ace 61 fields · synced Jun 19, 2026
- FDA UDI f8fa7166-7ea5-44ce-a615-faaa9eddb563 34 fields · synced May 30, 2026