SL11 Device Sterilizable Cover
EUDAMEDFDA UDIClass I (EU MDR)
by Amimon Ltd.
Identity
- Trade Name
- SL11 Device Sterilizable Cover EUDAMEDAmimon FDA UDI
- Generic Name
- Medical equipment handle cover, reusable FDA UDI
- Device Name
- SL11 Device Sterilizable Cover EUDAMED
- Model / Reference
- AMN_ASM_1030 EUDAMEDSL11 device Sterilizable Cover - AMN_ASM_1030 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817157020801 EUDAMEDFDA UDI
- Basic UDI-DI
- 817157020801CB EUDAMED
- FDA Product Code
- KQM FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical equipment handle cover, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
SL11 Device Sterilizable Cover by Amimon Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 817157020801CB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Amimon Ltd.
- EUDAMED SRN
- IL-MF-000036491
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 54fbd820-fa26-433c-9cf2-ff5e73f1e81e 61 fields · synced Jul 12, 2026
- FDA UDI 82bb3c1f-ef7b-4d13-bf34-01d0e9186801 32 fields · synced May 30, 2026