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Gel pad assortment for shockwave therapy
EUDAMEDFDA UDIClass I (EU MDR)
Ref 64235233Model 10000201129
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Electromechanical orthopaedic extracorporeal shock wave therapy system FDA UDI
- Device Name
- Gel pad assortment for shockwave therapy EUDAMEDGEL PAD ASSORTMENT FBL 10X5 G2 for use with PiezoWave 2, penetration depths 0 mm, 5 mm, 10 mm, 15 mm and 20 mm FDA UDI
- Model / Reference
- 10000201129 EUDAMED64235233 EUDAMEDFDA UDI
- Description
- GEL PAD ASSORTMENT FBL 10X5 G2 for use with PiezoWave 2, penetration depths 0 mm, 5 mm, 10 mm, 15 mm and 20 mm FDA UDI
Identifiers
- Catalog Number
- 64235233 FDA UDI
- Primary DI / UDI-DI
- 04055207064207 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520710122019-00177599R EUDAMED
- Direct Marketing DI
- 04055207064207 EUDAMED
- FDA Product Code
- ISA FDA UDI
- EMDN Code
- Z12139001 SHOCK WAVE THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Electromechanical orthopaedic extracorporeal shock wave therapy system 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gel pad assortment 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 | 405520710122019-00177599R | 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 a8ffb0bd-45c7-4ea3-be9c-3ef1d9aceb8f 61 fields · synced Jul 13, 2026
- FDA UDI 0ffdeae0-e3f4-46c2-9a31-6a7569a77f69 36 fields · synced May 30, 2026