Identity
- Trade Name
- Dual Action Pump - Hand Variant EUDAMEDDual Action Pump Hand FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- Dual Action Pump (Hand Variant) EUDAMEDThe Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract during stone management, while simultaneously draining the same volume. FDA UDI
- Model / Reference
- URO 058 EUDAMED1 FDA UDI
- Description
- The Dual Action Pump (DAP) is a user-controlled manual pump that delivers a bolus of irrigation fluid to the upper urinary tract during stone management, while simultaneously draining the same volume. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05906168942228 EUDAMEDFDA UDI
- Basic UDI-DI
- 59061689422URO058LG EUDAMED
- FDA Product Code
- FFD FDA UDI
- EMDN Code
- Z12019007 IRRIGATORS EUDAMED
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4370 FDA UDI
- Market of Registration
- Poland 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic spray catheter, single-use
Dual Action Pump - Hand Variant by Calyx Medical Sp. z o.o. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic spray catheter, single-use.
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- Measuring Jug 500 — Chaplet International Pvt Ltd · Class I
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 | 59061689422URO058LG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Calyx Medical Sp. z o.o.
- EUDAMED SRN
- PL-MF-000038787
Sources (2)
- EUDAMED b8012736-f6a6-4ef1-a7b1-c2fd436a186c 61 fields · synced Jun 20, 2026
- FDA UDI 38b61e64-8b36-4494-a355-245ef30c3d3d 35 fields · synced May 26, 2026