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Masterpuls One
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 27800.0002Ref 27800.0012Ref 27800.0003
Identity
- Trade Name
- MASTERPULS ONE EUDAMEDMASTERPULS® FDA UDI
- Generic Name
- Pressure-wave skin/body contouring system FDA UDI
- Device Name
- MASTERPULS ONE EUDAMEDThe MASTERPULS® ONE is a compressed air-operated ballistic pressure wave generator. FDA UDI
- Model / Reference
- 27800.0002 EUDAMED27800.0012 EUDAMED27800.0003 EUDAMEDONE FDA UDI
- Description
- The MASTERPULS® ONE is a compressed air-operated ballistic pressure wave generator. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630039101664 EUDAMED07630039101169 EUDAMEDFDA UDI07630039101114 EUDAMED07630039101107 EUDAMED
- Basic UDI-DI
- 76300391ESWT001-SZ EUDAMEDB-07630039101169 EUDAMEDB-07630039101114 EUDAMEDB-07630039101107 EUDAMED
- Direct Marketing DI
- 07630039101664 EUDAMED
- 510(k) Number
- K173692 FDA UDI
- FDA Product Code
- ISA FDA UDI
- EMDN Code
- Z120622,Z12101106,Z12139001,Z12169002,Z12169004 EUDAMEDZ120622,Z12139001 EUDAMED
- GMDN Term
- Pressure-wave skin/body contouring system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.5660 FDA UDI
- 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
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
Masterpuls One by Storz Medical AG — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 76300391ESWT001-SZ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 76300391ESWT001-SZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Storz Medical Ag
- EUDAMED SRN
- CH-MF-000014374
- Authorised Representative
- STORZ MEDICAL Deutschland GmbH DE-AR-000009017
Sources (5)
- EUDAMED 65788800-5baf-4140-b6a5-beff20087142 61 fields · synced Oct 6, 2026
- FDA UDI 05d4dce4-3b7f-483c-9858-ff43d0ff1003 34 fields · synced May 30, 2026
- EUDAMED c34af383-97d8-451f-a6e2-f9573bc98db8 61 fields · synced Jul 11, 2026
- EUDAMED 9c75f568-6555-402d-aeac-28270aa6adab 61 fields · synced Jul 11, 2026
- EUDAMED d704383b-f3b3-4446-840a-90be91d02f74 61 fields · synced Jul 13, 2026