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Ear Protector, Hard Cup
EUDAMEDClass I (EU MDR)
Ref 90-11000Model Ear Protector
Identity
- Device Name
- Ear Protector, Hard Cup EUDAMED
- Model / Reference
- Ear Protector EUDAMED90-11000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818501022915 EUDAMED
- Basic UDI-DI
- 081850102EarDressingAS EUDAMED
- EMDN Code
- Q0399 ENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Ear Protector, Hard Cup by Invotec International, Inc. — 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 | 081850102EarDressingAS | Class I | Active |
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Manufacturer
- Manufacturer
- Invotec International, Inc.
- EUDAMED SRN
- US-MF-000024855
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED fdaa2974-38da-4bbd-b4b8-9f99afe90e16 61 fields · synced Jun 18, 2026