Identity
- Trade Name
- NIBP cuff and accessories EUDAMEDMed-link FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDI
- Device Name
- NIBP cuff and accessories EUDAMED
- Model / Reference
- Y000DA1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944414038485 EUDAMED06944414017503 FDA UDI
- Basic UDI-DI
- 69444140007SS EUDAMED
- 510(k) Number
- K160530 FDA UDI
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Blood pressure cuff, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NIBP cuff and accessories by Shenzhen Med-link Electronics Tech 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 | 69444140007SS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Med-link Electronics Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011145
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED ca8aaf51-f414-435a-826a-f13e4a7fee2a 61 fields · synced Jun 19, 2026
- FDA UDI 95bfd2c5-b955-4ad4-827b-5759a181f3b7 33 fields · synced May 30, 2026