Identity
- Trade Name
- Master EUDAMEDEndoskopiepumpe Master distributed by KARL STORZ UP034C, 115V FDA UDI
- Generic Name
- Surgical suction pump FDA UDI
- Device Name
- Master EUDAMED
- Model / Reference
- 30.00.24 EUDAMED30.00.24 / UP034C FDA UDI
Identifiers
- Catalog Number
- 30.00.24 FDA UDI
- Primary DI / UDI-DI
- 07640108055293 EUDAMEDFDA UDI
- Basic UDI-DI
- 764010905suctionpumpUQ EUDAMED
- Direct Marketing DI
- 07640108055293 EUDAMED
- 510(k) Number
- K011601 FDA UDI
- FDA Product Code
- BTA FDA UDI
- EMDN Code
- Z120105 SURGICAL MEDICAL ASPIRATORS EUDAMED
- GMDN Term
- Surgical suction pump FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Germany 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
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 — 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 | 764010905suctionpumpUQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ardo medical AG
- EUDAMED SRN
- CH-MF-000016526
- Authorised Representative
- ARDO medical GmbH DE-AR-000014440
Sources (2)
- EUDAMED a795c9d9-fcf4-43e0-9ca1-863b809df18d 61 fields · synced Oct 5, 2026
- FDA UDI 010e7400-a1c5-4147-9ca2-1d0e2cd23f02 35 fields · synced May 30, 2026