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Device carts for shockwave therapy
EUDAMEDFDA UDIClass I (EU MDR)
Ref 100905Model 10000201138
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Medical device integration rack FDA UDI
- Device Name
- Device carts for shockwave therapy EUDAMEDPIEZOWAVE2 DEVICE TROLLEY for PiezoWave2 FDA UDI
- Model / Reference
- 10000201138 EUDAMED100905 EUDAMEDFDA UDI
- Description
- PIEZOWAVE2 DEVICE TROLLEY for PiezoWave2 FDA UDI
Identifiers
- Catalog Number
- 100905 FDA UDI
- Primary DI / UDI-DI
- 04055207008539 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017771PV EUDAMED
- Direct Marketing DI
- 04055207008539 EUDAMED
- FDA Product Code
- ISA FDA UDI
- EMDN Code
- Z12139001 SHOCK WAVE THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Medical device integration rack FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5660 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Device carts for shockwave therapy by Richard Wolf GmbH — Class I — 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 | 405520727052019-0017771PV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED b235da33-778f-42d9-a05c-016e8039c197 61 fields · synced Jul 13, 2026
- FDA UDI 5ab32c17-5f77-4e55-bdb4-c94dc3d05820 35 fields · synced May 30, 2026