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Sterilisation Tray
EUDAMEDFDA UDIClass I (EU MDR)
Ref 141527Ref 172099Ref 242794
Identity
- Trade Name
- STERILISATION TRAY EUDAMEDFDA UDI
- Generic Name
- Surgical camera holder FDA UDI
- Device Name
- ENDOFIX exo EUDAMEDSOLOASSIST II EUDAMEDRoboFIX EUDAMED
- Model / Reference
- 141527 EUDAMED172099 EUDAMEDFDA UDI242794 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260463845273 EUDAMED04260463840995 EUDAMEDFDA UDI04260463847949 EUDAMED
- Basic UDI-DI
- 4260463840028V EUDAMED4260463840018T EUDAMED42604638400899 EUDAMED
- Direct Marketing DI
- 04260463845273 EUDAMED04260463840995 EUDAMED04260463847949 EUDAMED
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Surgical camera holder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- France EUDAMEDPoland EUDAMEDGermany 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument tray, reusable
Sterilisation Tray by Aktormed GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 4260463840028V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AKTORmed GmbH
- EUDAMED SRN
- DE-MF-000006136
Sources (4)
- EUDAMED 4830dea3-7d2b-4548-a7d2-e34d7a70ccb4 61 fields · synced Jul 30, 2026
- EUDAMED ac302ee5-29d6-45f9-95d5-3fd4a155b59b 61 fields · synced May 18, 2026
- EUDAMED 2f0f9390-476b-4517-92ae-75a94e417938 61 fields · synced May 18, 2026
- FDA UDI 8ea6d60b-d78e-436e-af49-ede70d59de94 32 fields · synced May 30, 2026