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Master
EUDAMEDFDA 510(k)FDA UDIClass IIa (EU MDR)
Ref 30.00.39Ref 30.00.23Ref 31.00.31510(k) K011601Ref 31.00.21Ref 31.00.22
Identity
- Trade Name
- Master EUDAMEDSenator EUDAMEDEndoskopiepumpe Senator distributed by KARL STORZ UP030C, 115V FDA UDI
- Generic Name
- Surgical suction pump FDA UDI
- Device Name
- Master EUDAMED
- Model / Reference
- 30.00.39 EUDAMED30.00.23 EUDAMED31.00.31 EUDAMED31.00.21 EUDAMED31.00.22 EUDAMED31.00.22 / UP030C FDA UDI
Identifiers
- Catalog Number
- 31.00.22 FDA UDI
- Primary DI / UDI-DI
- 07640109055322 EUDAMED07640108055286 EUDAMED07640109055438 EUDAMED07640108053374 EUDAMEDFDA UDI07640108053367 EUDAMED
- Basic UDI-DI
- B-07640109055322 EUDAMED764010905suctionpumpUQ EUDAMED
- Direct Marketing DI
- 07640108055286 EUDAMED07640109055438 EUDAMED07640108053367 EUDAMED07640108053374 EUDAMED
- 510(k) Number
- FDA Product Code
- BTA FDA 510(k)FDA UDI
- EMDN Code
- Z120105 SURGICAL MEDICAL ASPIRATORS EUDAMED
- GMDN Term
- Surgical suction pump FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Master by Ardo medical AG — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011601 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-07640109055322 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07640109055322 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ardo medical AG
- EUDAMED SRN
- CH-MF-000016526
- Authorised Representative
- ARDO medical GmbH DE-AR-000014440
Sources (7)
- EUDAMED 2ee17485-0e60-4615-97ab-85a7ee2adf3c 61 fields · synced Oct 6, 2026
- EUDAMED 417d2792-fa6b-462f-a409-d4512dd39ee7 61 fields · synced May 17, 2026
- EUDAMED 038e854c-da37-4d89-b0b9-d3cd596f638a 61 fields · synced May 17, 2026
- FDA 510(k) K011601 24 fields · synced May 18, 2026
- FDA UDI 748bca77-6f97-418a-8258-3f3960a6d987 35 fields · synced May 30, 2026
- EUDAMED bfe31580-ef76-4696-81eb-4f7f3c9c5c2c 61 fields · synced Jul 9, 2026
- EUDAMED fc92f530-c225-4366-86dd-f6073b89d1a7 61 fields · synced Jul 16, 2026