Identity
- Trade Name
- D-ACTOR 100 EUDAMEDD-ACTOR® FDA UDI
- Generic Name
- Hand-held electric massager FDA UDI
- Device Name
- D-ACTOR 100 EUDAMEDEquipment for the extracorporeal pneumatically operated ballistic pressure wave therapy. FDA UDI
- Model / Reference
- 23300.0100 EUDAMED100 [010x] FDA UDI
- Description
- Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630039100476 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07630039100476 EUDAMED
- FDA Product Code
- ISA FDA UDI
- EMDN Code
- Z120622,Z12139001 EUDAMED
- GMDN Term
- Hand-held electric massager FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.5660 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
D-Actor 100 by Storz Medical AG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07630039100476 | 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 (2)
- EUDAMED 962bbbda-41b9-4fc4-a1b1-e0c5522baeae 61 fields · synced Oct 6, 2026
- FDA UDI f6af0ba9-be68-44d4-9a9d-102cbc4eeb60 34 fields · synced May 29, 2026