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mesilife
EUDAMEDFDA UDIClass I (EU MDR)
Ref latex bulb with end valveRef MC-220Model MC-220、MC-230、MC-410、MC-510、MC-210Ref MC-230
Identity
- Trade Name
- mesilife EUDAMEDEXANOVO FDA UDI
- Generic Name
- Mechanical external stethoscope FDA UDI
- Device Name
- Aneroid Sphygmomanometer Accessories EUDAMEDStethoscope EUDAMEDSingle head stethoscope FDA UDI
- Model / Reference
- latex bulb with end valve EUDAMEDMC-230 EUDAMEDFDA UDIMC-220、MC-230、MC-410、MC-510、MC-210 EUDAMEDMC-220 EUDAMED
- Description
- Single head stethoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970691009023 EUDAMED06970691005018 EUDAMED06970691006008 EUDAMED06970691000013 FDA UDI
- Basic UDI-DI
- B-06970691009023 EUDAMED697069100MC002AJ EUDAMED
- Direct Marketing DI
- 06970691005018 EUDAMED06970691006008 EUDAMED
- FDA Product Code
- LDE FDA UDI
- EMDN Code
- Z12030280 VITAL SIGNS MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDC9005 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
- Türkiye 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
mesilife by Wuxi Exanovo Medical Instrument Co., Ltd. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06970691009023 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06970691009023 | 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 (4)
- EUDAMED 75a6ffa1-0cdc-4801-9c29-faf6921e9b6e 61 fields · synced Oct 7, 2026
- FDA UDI 41dc125c-f3fd-44e1-934f-29c59f37023f 33 fields · synced May 30, 2026
- EUDAMED 5435a3b2-046f-4a0b-9e7e-74a228b504d3 61 fields · synced Jun 18, 2026
- EUDAMED dfbd0e8c-5c15-4785-b15f-f39fda173bb0 61 fields · synced Jul 12, 2026