Identity
- Trade Name
- PRO-Diary Motion EUDAMEDPRO-Diary FDA UDI
- Generic Name
- Kinesiology ambulatory recorder FDA UDI
- Device Name
- PRO-Diary EUDAMEDAmbulatory Physical Activity Recorder with Electronic Patient diary FDA UDI
- Model / Reference
- 05-111 EUDAMEDPDM FDA UDI
- Description
- Ambulatory Physical Activity Recorder with Electronic Patient diary FDA UDI
Identifiers
- Catalog Number
- 05-111 FDA UDI
- Primary DI / UDI-DI
- B329PDM25 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B329PDM01XT EUDAMED
- Direct Marketing DI
- B329PDM25 EUDAMED
- 510(k) Number
- K132764 FDA UDI
- FDA Product Code
- LEL FDA UDI
- EMDN Code
- Z12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Kinesiology ambulatory recorder FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Market of Registration
- Denmark 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
PRO-Diary Motion by CamNtech Ltd — 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 | ++B329PDM01XT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CamNtech Ltd
- EUDAMED SRN
- GB-MF-000004683
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 24552709-a43a-4856-9250-8cd7b0707a08 61 fields · synced Jun 8, 2026
- FDA UDI de9c8ce1-401d-45cb-a104-c79a3886e680 36 fields · synced May 30, 2026