Identity
- Trade Name
- Optipulse EUDAMEDPulseFlow DF™ FDA UDI
- Generic Name
- Intermittent venous compression system FDA UDI
- Device Name
- Optipulse EUDAMED
- Model / Reference
- PB01 EUDAMEDPB01 Left C FDA UDI
Identifiers
- Catalog Number
- PFDFs-Left C FDA UDI
- Primary DI / UDI-DI
- 05060666850048 EUDAMEDFDA UDI
- Basic UDI-DI
- 506066685PB018U EUDAMED
- 510(k) Number
- K150806 FDA UDI
- FDA Product Code
- JOW FDA UDI
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Intermittent venous compression system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5800 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
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
Category: Dermatological laser beam guiding handpiece
Optipulse by Compedica Limited — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 506066685PB018U | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Compedica Limited
- EUDAMED SRN
- UK-MF-000038316
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 14d2e4fe-1341-4c08-8bfe-483fe1833caa 61 fields · synced Jul 9, 2026
- FDA UDI 6488d796-2ac1-4e4e-852c-34dac2860214 36 fields · synced May 30, 2026