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EHL-Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P201400FSTRef P303000SSTRef P243000SSTRef P303000FSTRef P45600FST
Identity
- Trade Name
- EHL-Probe FDA UDI
- Generic Name
- Electrohydraulic lithotripsy system FDA UDI
- Device Name
- EHL-Probe EUDAMEDDiameter of 2,4 Fr. with a length of 3 meter. Proximally reinforced FDA UDIDiameter of 3 Fr. with a length of 3 meter FDA UDIDiamaeter of 3 Fr. with a length of 3 meter. Proximally reinforced. FDA UDIDiamater of 4,5 Fr. with a lentgh of 0,6 meter. FDA UDI
- Model / Reference
- P201400FST EUDAMEDP243000SST EUDAMEDFDA UDIP303000FST EUDAMEDFDA UDIP303000SST EUDAMEDFDA UDIP45600FST EUDAMEDFDA UDI
- Description
- Diameter of 2,4 Fr. with a length of 3 meter. Proximally reinforced FDA UDIDiameter of 3 Fr. with a length of 3 meter FDA UDIDiamaeter of 3 Fr. with a length of 3 meter. Proximally reinforced. FDA UDIDiamater of 4,5 Fr. with a lentgh of 0,6 meter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260667540035 EUDAMED04260667540059 EUDAMEDFDA UDI04260667540158 EUDAMEDFDA UDI04260667540134 EUDAMEDFDA UDI04260667540172 EUDAMEDFDA UDI
- Basic UDI-DI
- 426066754EHL-PROBE6M EUDAMED
- Direct Marketing DI
- 04260667540035 EUDAMED04260667540134 EUDAMED04260667540059 EUDAMED04260667540158 EUDAMED04260667540172 EUDAMED
- 510(k) Number
- K230488 FDA UDI
- FDA Product Code
- FFK FDA UDI
- EMDN Code
- Z12020385 ENDOSCOPIC LITHOTRIPSY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electrohydraulic lithotripsy system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4480 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
EHL-Probe by Walz Elektronik Gmbh — 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 | 426066754EHL-PROBE6M | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Walz Elektronik GmbH
- EUDAMED SRN
- DE-MF-000006132
Sources (9)
- EUDAMED f2156609-c762-4857-a949-647f793d2c08 61 fields · synced Jul 24, 2026
- FDA UDI 887ae8ad-e940-4d1a-afb8-39ab7ed245e4 34 fields · synced May 30, 2026
- FDA UDI 1609c680-7c3f-4c3e-a896-c6b4066e60be 34 fields · synced May 30, 2026
- FDA UDI ea9d175f-96a4-48ba-aebe-7ebfb06e1c96 34 fields · synced May 30, 2026
- FDA UDI 6b13f56d-dd93-4907-884c-35aef991455b 34 fields · synced May 30, 2026
- EUDAMED fe1d6c46-37d9-4dc7-9a31-900750e49b8a 61 fields · synced Jul 9, 2026
- EUDAMED 57b3ca26-b770-42dd-bd87-b6ab14e98845 61 fields · synced Jul 21, 2026
- EUDAMED e7d3ecc5-3c98-4074-8582-6ed136283849 61 fields · synced Jul 23, 2026
- EUDAMED 6f73b25e-3ad2-45dc-b82e-e3175dd1ddf4 61 fields · synced Jul 24, 2026