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Single-use Rosen Round Ear Specula 4mm, non sterile
EUDAMEDClass I (EU MDR)
Ref ESP1004Model Non Sterile Ear Specula
Identity
- Trade Name
- Single-use Rosen Round Ear Specula 4mm, non sterile EUDAMED
- Model / Reference
- Non Sterile Ear Specula EUDAMEDESP1004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060212050182 EUDAMED
- Basic UDI-DI
- 506021205TD20WU EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Single-use Rosen Round Ear Specula 4mm, non sterile by Dtr Medical 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 | 506021205TD20WU | Class I | Active |
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Manufacturer
- Manufacturer
- Dtr Medical Ltd
- EUDAMED SRN
- GB-MF-000023112
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 338aecd7-6be6-4463-8898-5972775e2389 61 fields · synced Jun 19, 2026