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Wireless Z
EUDAMEDClass I (EU MDR)
Ref 5080797Model Wireless Z, Wireless Z+Ref 5080904
Identity
- Trade Name
- Wireless Z EUDAMEDWireless Z+ EUDAMED
- Device Name
- Surgical Headlight EUDAMED
- Model / Reference
- Wireless Z, Wireless Z+ EUDAMED5080797 EUDAMED5080904 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941877811976 EUDAMED06941877819781 EUDAMED
- Basic UDI-DI
- 697259778LU002RP EUDAMED
- Direct Marketing DI
- 06941877811976 EUDAMED06941877819781 EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDCzechia 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
Wireless Z by Changzhou Sifary Medical Technology Co., Ltd. — Class I — 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 | 697259778LU002RP | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 39bab761-70de-408c-b8eb-47d86b123a5a 61 fields · synced Jul 8, 2026
- EUDAMED 1ad8f8bb-964d-462c-a30a-871147cf4d40 61 fields · synced May 18, 2026