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Duolith Sd1 T-Top
EUDAMEDFDA 510(k)FDA UDIClass IIb (EU MDR)
Ref 21362.1000510(k) K202112Ref 21362.0100Ref 21362.0102Ref 19880.0001
Identity
- Trade Name
- DUOLITH SD1 T-TOP EUDAMEDDUOLITH SD1 Tower EUDAMEDDUOLITH® FDA UDI
- Generic Name
- Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system FDA UDI
- Device Name
- DUOLITH SD1 T-TOP EUDAMEDDUOLITH SD1 Tower EUDAMEDThe device is indicated for extracorporeal shock wave treatment. FDA UDI
- Model / Reference
- 21362.1000 EUDAMED21362.0100 EUDAMED21362.0102 EUDAMED19880.0001 EUDAMEDSD1 T-Top FDA UDI
- Description
- The device is indicated for extracorporeal shock wave treatment. FDA UDI
Identifiers
- Catalog Number
- 21362.0102 FDA UDI
- Primary DI / UDI-DI
- 07630039101626 EUDAMED07630039101398 EUDAMEDFDA UDI07630039100599 EUDAMED07630039100933 EUDAMED
- Basic UDI-DI
- 76300391ESWT006-TG EUDAMEDB-07630039100599 EUDAMEDB-07630039101398 EUDAMEDB-07630039100933 EUDAMED
- Direct Marketing DI
- 07630039101626 EUDAMED
- PMA Number
- P080028 FDA UDI
- 510(k) Number
- FDA Product Code
- PZL FDA 510(k)FDA UDINBN FDA UDI
- EMDN Code
- Z12040203,Z12040205,Z120622,Z12101106,Z12139001,Z12169002,Z12169004 EUDAMEDZ12139001 SHOCK WAVE THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)Class III FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4685 FDA 510(k)
- Regulation Number
- 878.4685 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMEDItaly 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
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
MR Unsafe FDA UDI
Duolith Sd1 T-Top by Storz Medical AG — Class IIb — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 76300391ESWT006-TG | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K202112 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 76300391ESWT006-TG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Storz Medical Ag
- EUDAMED SRN
- CH-MF-000014374
- Authorised Representative
- STORZ MEDICAL Deutschland GmbH DE-AR-000009017
Sources (6)
- EUDAMED 74c35a78-f460-4ffb-a5ce-985b4ef21f23 61 fields · synced Jul 25, 2026
- FDA 510(k) K202112 24 fields · synced May 18, 2026
- FDA UDI dfe04ebd-fc0b-4e5d-8104-c029e1512534 35 fields · synced May 30, 2026
- EUDAMED 725fae20-8214-44fe-93d7-ad11774ee0e8 61 fields · synced Jul 9, 2026
- EUDAMED cce5f21c-2616-41c9-bdef-9a523e8e92ce 61 fields · synced Jul 12, 2026
- EUDAMED 26a56854-e134-47af-9bae-b07244ff55fb 61 fields · synced Jul 25, 2026