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Aneroid Sphygmomanometer
EUDAMEDFDA UDIClass I (EU MDR)
Ref N/AModel DF-A01、DF-A02、DF-A03、DF-A04、DF-A05、DF-A06
Identity
- Trade Name
- Aneroid Sphygmomanometer EUDAMEDNA FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Aneroid sphygmomanometer EUDAMED
- Model / Reference
- DF-A01、DF-A02、DF-A03、DF-A04、DF-A05、DF-A06 EUDAMEDN/A EUDAMEDKT-A05 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970784670031 EUDAMEDFDA UDI
- Basic UDI-DI
- 6970784670101CX EUDAMED
- 510(k) Number
- K081951 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- C9006 ANEROID SPHYGMOMANOMETERS EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- France 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
Yes
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Aneroid Sphygmomanometer by Wenzhou Dongfang Medical Instruments Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 6970784670101CX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wenzhou Dongfang Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000043057
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 7f215de3-0f04-4077-a383-9d8f2545cc9d 61 fields · synced Jun 19, 2026
- FDA UDI 2eaae218-a275-4a74-afd6-108479a7f7e4 33 fields · synced May 30, 2026