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S_ite Oz 20ite Lig8lblk Blk
EUDAMEDClass IIa (EU MDR)
Ref 21040140Model INSTANT FIT
by Wsaud A/S
Identity
- Trade Name
- S_ITE OZ 20ITE LIG8LBLK BLK EUDAMED
- Model / Reference
- INSTANT FIT EUDAMED21040140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714880245332 EUDAMED
- Basic UDI-DI
- 5714880-WSA-28-30-4J EUDAMED
- EMDN Code
- Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
S_ite Oz 20ite Lig8lblk Blk by Wsaud A/S — 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 | 5714880-WSA-28-30-4J | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (1)
- EUDAMED 14ea4bf6-0a29-4356-8497-27a90f583f37 61 fields · synced Jul 10, 2026