Identity
- Trade Name
- 10K EUDAMEDFDA UDI
- Generic Name
- Arthroscopic irrigation/insufflation system FDA UDI
- Device Name
- Orthopedic, Active, Fluid Delivery, Irrigation System, Single Pump, Arthroscopic/Laparoscopic EUDAMEDIRRIGATION CONSOLE 10K FDA UDI
- Model / Reference
- 10K EUDAMEDFDA UDI
- Description
- IRRIGATION CONSOLE 10K FDA UDI
Identifiers
- Catalog Number
- 10K FDA UDI
- Primary DI / UDI-DI
- 20845854041106 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20845854041106 EUDAMED
- FDA Product Code
- HRX FDA UDIGCJ FDA UDI
- EMDN Code
- A03010201 ARTHROSCOPIC IRRIGATION CONTROLLERS EUDAMED
- GMDN Term
- Arthroscopic irrigation/insufflation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI876.1500 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
10k by Conmed Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20845854041106 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 63d5f98a-7e29-4bd8-956a-8daa2e6b8161 61 fields · synced May 30, 2026
- FDA UDI 82c3bf50-1324-4b8c-8268-85da9f8e81d0 37 fields · synced May 30, 2026