Identity
- Trade Name
- Clarus Holter EUDAMEDH3R FDA UDI
- Generic Name
- Telemetric electrocardiographic ambulatory recorder FDA UDI
- Device Name
- H3R 3-Lead Holter Recorder FDA UDI
- Model / Reference
- H3R-0039 EUDAMEDFDA UDI
- Description
- H3R 3-Lead Holter Recorder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811331010251 EUDAMEDFDA UDI
- Basic UDI-DI
- 081133101H3R-0039AY EUDAMED
- Direct Marketing DI
- 00811331010251 EUDAMED
- 510(k) Number
- K102507 FDA UDI
- FDA Product Code
- DSI FDA UDI
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
- GMDN Term
- Telemetric electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Clarus Holter by Tz Medical, Inc. — Class IIa — 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 | 081133101H3R-0039AY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- TZ Medical inc
- EUDAMED SRN
- US-MF-000027311
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED bf259964-5a62-4071-89bb-db1200ab8f29 61 fields · synced Jun 19, 2026
- FDA UDI 72f2e5bc-47d9-4fc1-a9ea-ddaaebb14d7d 34 fields · synced May 30, 2026