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SL11 Device Sterilizable Cover
EUDAMEDFDA UDIClass I (EU MDR)
Ref AMN_ASM_1030Model AMN_ASM_1030
by Rocoto Inc.
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 EUDAMEDSL11 Sterilizable Cover FDA UDI
- Model / Reference
- AMN_ASM_1030 EUDAMEDSL11 Sterilizable Cover - AMN_ASM_1030 FDA UDI
- Description
- SL11 Sterilizable Cover FDA UDI
Identifiers
- Catalog Number
- AMN_ASM_1030 FDA UDI
- Primary DI / UDI-DI
- 00860014100659 EUDAMEDFDA UDI
- Basic UDI-DI
- 008600141006598Q 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
- Austria 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
SL11 Device Sterilizable Cover by Rocoto Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 008600141006598Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rocoto Inc.
- EUDAMED SRN
- US-MF-000045904
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED 4e979016-1781-4392-ba1a-165f54103093 61 fields · synced Jul 14, 2026
- FDA UDI d4b3a4ea-1346-464e-8670-aa64adf62dd9 34 fields · synced May 30, 2026