← Back to catalogue
Hand Control Interface Syk
EUDAMEDFDA UDIClass I (EU MDR)
Ref 72205363Model INTERFACE DE COMMANDE MANUELLE
by Hemodia Sas
Identity
- Trade Name
- HAND CONTROL INTERFACE SYK EUDAMEDDOUBLEFLO FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- INTERFACE DE COMMANDE MANUELLE EUDAMEDHAND CONTROL INTERFACE SYK FDA UDI
- Model / Reference
- INTERFACE DE COMMANDE MANUELLE EUDAMED72205363 EUDAMEDA FDA UDI
- Description
- HAND CONTROL INTERFACE SYK FDA UDI
Identifiers
- Catalog Number
- 72205363 FDA UDI
- Primary DI / UDI-DI
- 03661379196038 EUDAMEDFDA UDI
- Basic UDI-DI
- 3661379FAB0500001EJ EUDAMED
- 510(k) Number
- K221919 FDA UDI
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- Z1202110201 MOTORISED ARTHROSCOPIC SURGERY SYSTEMS EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hand Control Interface Syk by Hemodia Sas — 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 | 3661379FAB0500001EJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hemodia Sas
- EUDAMED SRN
- FR-MF-000007191
Sources (2)
- EUDAMED 2564213f-f33f-4d03-aa90-71c38ce9cc73 61 fields · synced Jul 18, 2026
- FDA UDI f6e37c03-2b83-467a-b76c-b4d195d34bee 35 fields · synced May 29, 2026