myPatch®sl
Ref 3000sl
myPatch®sl (3000sl) is a Class IIa device made by dms-service, LLC, registered in EUDAMED on 10 Mar 2022 (Basic UDI-DI 08575220053000slFB) with CE/MDR certificate 28620238065 valid until 14 Aug 2027, expiring as of 23 Oct 2026.
Expiring
CE MDR
Valid until
14 Aug 2027
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number28620238065 | Date10 Feb 2026 | StatusExpiring |
Official records
- EUDAMED public site 08575220053000slFB
Certificates
- 28620238065 Expiring
Quality management system EU MDR
- Certifier
- Intertek Medical Notified Body AB 2862
- Issued
- 10 Feb 2026
- Expires
- 14 Aug 2027
Timeline
- Registered EUDAMED 08575220053000slFB
- Certificate issued EUDAMED 28620238065
- Certificate expires EUDAMED 28620238065
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Expiring
Specification
- Model / reference
- 3000sl
- Primary DI / UDI-DI
- 00857522005101
- Basic UDI-DI
- 08575220053000slFB
- Direct marketing DI
- 00857522005101
- EMDN code
- Z12050403 ECG holter recorders
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- US-MF-000008977
- Authorised representative
- QNET B.V. NL-AR-000002695
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