Identity
- Trade Name
- myPatch®sl EUDAMED
- Device Name
- myPatch®sl EUDAMED
- Model / Reference
- 3000sl EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00857522005101 EUDAMED
- Basic UDI-DI
- 08575220053000slFB EUDAMED
- Direct Marketing DI
- 00857522005101 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
myPatch®sl by dms-service, LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08575220053000slFB | Class IIa | Active |
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Manufacturer
- Manufacturer
- dms-service, LLC
- EUDAMED SRN
- US-MF-000008977
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (1)
- EUDAMED 8318a18c-0dff-450d-99df-b3696d06ddea 61 fields · synced Jun 19, 2026