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Kit Styletto 7x Us Demo Blk Blkg
EUDAMEDClass IIa (EU MDR)
Ref 11000401Model SLIM RIC
by Signia GmbH
Identity
- Trade Name
- KIT STYLETTO 7X US DEMO BLK BLKG EUDAMED
- Model / Reference
- SLIM RIC EUDAMED11000401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04063006015443 EUDAMED
- Basic UDI-DI
- B-04063006015443 EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) 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
Kit Styletto 7x Us Demo Blk Blkg by Signia GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04063006015443 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Signia GmbH
- EUDAMED SRN
- DE-MF-000017173
Sources (1)
- EUDAMED ad99ecda-32e8-4746-9682-d1ba2c80c57d 61 fields · synced Jul 8, 2026