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Rosner
EUDAMEDFDA UDIClass I (EU MDR)
Ref MC-220Model MC-220、MC-230、MC-410、MC-510、MC-210
Identity
- Trade Name
- ROSNER EUDAMEDEXANOVO FDA UDI
- Generic Name
- Mechanical external stethoscope FDA UDI
- Device Name
- Stethoscope EUDAMEDDual head stethoscope FDA UDI
- Model / Reference
- MC-220、MC-230、MC-410、MC-510、MC-210 EUDAMEDMC-220 EUDAMEDFDA UDI
- Description
- Dual head stethoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970691005001 EUDAMED06970691000020 FDA UDI
- Basic UDI-DI
- 697069100MC002AJ EUDAMED
- FDA Product Code
- LDE FDA UDI
- EMDN Code
- C9005 PHONENDOSCOPES AND STETHOSCOPES EUDAMED
- GMDN Term
- Mechanical external stethoscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.1875 FDA UDI
- Market of Registration
- Austria 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Rosner by Wuxi Exanovo Medical Instrument Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 697069100MC002AJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wuxi Exanovo Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000021396
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED d7f3159e-81d7-4b17-879f-a47f180760d8 61 fields · synced Jun 18, 2026
- FDA UDI 53abff98-23d7-4a15-b52d-3a569c02291b 33 fields · synced May 30, 2026