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Ear Syringe
EUDAMEDClass I (EU MDR)
Ref Ear Syringe 490mlModel 8/15/25/27/30/33/35/41/55/60/65/70/75/90/120/125/135/175/200/206/205/250/317/330/490/700ml、1/2/3oz
Identity
- Device Name
- Ear Syringe EUDAMED
- Model / Reference
- 8/15/25/27/30/33/35/41/55/60/65/70/75/90/120/125/135/175/200/206/205/250/317/330/490/700ml、1/2/3oz EUDAMEDEar Syringe 490ml EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975918771127 EUDAMED
- Basic UDI-DI
- 697591877ES11SW EUDAMED
- EMDN Code
- Z12149085 VARIOUS ENT INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Ear Syringe by Nanjing Ihome Comfort 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 | 697591877ES11SW | Class I | Active |
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Manufacturer
- Manufacturer
- Nanjing Ihome Comfort Co., Ltd
- EUDAMED SRN
- CN-MF-000037214
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 64300cbf-b2ae-4d9a-b489-aa2199748c88 61 fields · synced Jun 19, 2026