MD 11 System Receiver
EUDAMEDFDA UDIClass I (EU MDR)
by Rocoto Inc.
Identity
- Trade Name
- MD 11 System Receiver EUDAMEDAmimon FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- MD 11 System Receiver EUDAMEDMD11 Rx device FDA UDI
- Model / Reference
- MDWL1_B1N1RX EUDAMEDMD11 Rx device - MDWL1_B1N1RX FDA UDI
- Description
- MD11 Rx device FDA UDI
Identifiers
- Catalog Number
- MDWL1_B1N1RX FDA UDI
- Primary DI / UDI-DI
- 00860014100635 EUDAMEDFDA UDI
- Basic UDI-DI
- 008600141006358A EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Market of Registration
- Austria 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
MD 11 System Receiver by Rocoto Inc. — 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 | 008600141006358A | 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 92467c91-8181-4def-a994-b2d39f73da36 61 fields · synced Jun 19, 2026
- FDA UDI d8cc7c98-005b-4c64-a78d-0ccffd99cb75 34 fields · synced May 30, 2026