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Reusable ear funnels, Ø 4.0 mm, 10 pcs.
EUDAMEDFDA UDIClass I (EU MDR)
Ref 01.72213.001
Identity
- Trade Name
- Reusable ear funnels, Ø 4.0 mm, 10 pcs. EUDAMEDReusable ear funnels Ø 4.0 mm, 10 pcs. FDA UDI
- Generic Name
- Ear speculum, reusable FDA UDI
- Device Name
- Otoscopes and diagnostic sets EUDAMED
- Model / Reference
- 01.72213.001 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04030155000774 EUDAMEDFDA UDI
- Basic UDI-DI
- 4030155KaWe0101YR EUDAMED
- FDA Product Code
- FXG FDA UDI
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
- GMDN Term
- Ear speculum, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.1800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Otoscope, endoscopic
Reusable ear funnels, Ø 4.0 mm, 10 pcs. by Kirchner & Wilhelm GmbH + Co KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Otoscope, endoscopic.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4030155KaWe0101YR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kirchner & Wilhelm GmbH + Co KG
- EUDAMED SRN
- DE-MF-000006338
Sources (2)
- EUDAMED 1837d6e1-d2a8-48f2-9a3b-f093f6ec7a95 61 fields · synced Aug 1, 2026
- FDA UDI cf6580e3-1dfb-4e6c-a6df-6c4d85ac464b 32 fields · synced May 27, 2026