Identity
- Trade Name
- Pharma【+】 EUDAMEDAneroid Sphymomanometer With Stethoscope EUDAMEDEXANOVO FDA UDI
- Generic Name
- Aneroid manual sphygmomanometer FDA UDI
- Device Name
- Mercury free clinical thermometer EUDAMEDAneroid Sphygmomanometer EUDAMEDwith stethoscope FDA UDI
- Model / Reference
- MC-10 EUDAMEDMC-20 EUDAMED600051 EUDAMEDMC-50 FDA UDI
- Description
- with stethoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970691000068 EUDAMEDFDA UDI
- Basic UDI-DI
- 697069100MC003AL EUDAMEDB-06970691000068 EUDAMED
- 510(k) Number
- K203620 FDA UDI
- FDA Product Code
- LDE FDA UDIDXQ FDA UDI
- EMDN Code
- V03010104 LIQUID EXPANSION THERMOMETERS EUDAMEDC9006 ANEROID SPHYGMOMANOMETERS EUDAMED
- GMDN Term
- Aneroid manual sphygmomanometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.1875 FDA UDI870.1120 FDA UDI
- Market of Registration
- Italy 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Pharma【+】 by Wuxi Exanovo Medical Instrument Co., Ltd. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 697069100MC003AL | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697069100MC003AL | 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 (3)
- EUDAMED 2f4ce0f7-2999-423c-a2d7-1d8ba3dcfb2d 61 fields · synced Oct 6, 2026
- FDA UDI 7a5abd21-53c3-4b9c-b9e9-149c8fbe1fef 34 fields · synced May 30, 2026
- EUDAMED 83ee02da-0b08-4918-98f1-8bc60141b536 61 fields · synced Aug 1, 2026