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NIBP cuff and accessories
EUDAMEDFDA UDIClass I (EU MDR)
Ref Y000A1-A04Model Y000DA1Ref Y000DSN1-5#Ref YA100A03-10Ref Y000L1Ref Y000T1Ref Y000DSN1-2#Ref Y000I2Ref Y000DLA1Ref Y000DSA2Ref A24Ref Y000A1Ref Y000RA2Ref YA07A08-10Ref Y000RSA1-A118Ref Y000DSN2-4#
Identity
- Trade Name
- NIBP cuff and accessories EUDAMEDMed-link FDA UDI
- Generic Name
- Blood pressure cuff, single-use FDA UDIBlood pressure cuff, reusable FDA UDI
- Device Name
- NIBP cuff and accessories EUDAMED
- Model / Reference
- Y000DA1 EUDAMEDY000A1-A04 EUDAMEDY000DSN1-5# EUDAMEDFDA UDIY000DLA1 EUDAMEDFDA UDIY000L1 EUDAMEDFDA UDIY000DSN1-2# EUDAMEDFDA UDIYA100A03-10 EUDAMEDY000T1 EUDAMEDY000I2 EUDAMEDY000DSA2 EUDAMEDA24 EUDAMEDY000A1 EUDAMEDY000RA2 EUDAMEDYA07A08-10 EUDAMEDY000RSA1-A118 EUDAMEDY000DSN2-4# EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944414042482 EUDAMED06944414045087 EUDAMED06944414037891 EUDAMED06944414042581 EUDAMED06944414013994 EUDAMED06944414033640 EUDAMED06944414077224 EUDAMED06944414042574 EUDAMED06944414056090 EUDAMED06944414094177 EUDAMED06944414013888 EUDAMED06944414059770 EUDAMED06944414013956 EUDAMED06944414087438 EUDAMED06944414073509 EUDAMED06944414036337 FDA UDI06944414021449 FDA UDI06944414049238 FDA UDI06944414036276 FDA UDI
- Basic UDI-DI
- 69444140007SS EUDAMED
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Blood pressure cuff, single-use FDA UDIBlood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA 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 UDIFDA 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 (19)
- EUDAMED 4e100907-c6bc-4644-a1b2-2b0f307d3d30 61 fields · synced Sep 17, 2026
- FDA UDI 8f07e1d1-2294-4020-a15d-f14a5ab79692 33 fields · synced May 29, 2026
- FDA UDI d5150e8b-c7a7-4918-811f-c01839313f42 33 fields · synced May 30, 2026
- FDA UDI ca661690-8fbd-4dab-9d0b-3e1c57598472 33 fields · synced May 30, 2026
- FDA UDI 87054d4b-edaa-4fce-a2ef-47f57353a4de 33 fields · synced May 30, 2026
- EUDAMED b9734d5e-2082-4d8b-b3d3-bac8a4e2fcff 61 fields · synced Jul 8, 2026
- EUDAMED 05ea9e77-6c60-4402-92fc-4f33b9c23d21 61 fields · synced Jul 8, 2026
- EUDAMED 88bc0408-c260-495f-8372-a560c46f1056 61 fields · synced Jul 8, 2026
- EUDAMED 45079d7c-68ad-4034-b618-148adbd29eb2 61 fields · synced Jul 8, 2026
- EUDAMED 368ec5d8-8566-4fb6-91ef-b2ba28837b78 61 fields · synced Jul 8, 2026
- EUDAMED 09a2bd15-7210-46b2-96eb-cc0fa0449cdf 61 fields · synced Jul 8, 2026
- EUDAMED c50dc108-767f-4a7c-a05e-c9693a6ec4b5 61 fields · synced Jul 8, 2026
- EUDAMED 70d68a14-6ba6-4faa-8c7c-515293a2e5ed 61 fields · synced Jul 8, 2026
- EUDAMED 543417e0-f220-4c2f-afd9-f2a7d78c614f 61 fields · synced Aug 1, 2026
- EUDAMED 3f3ad9ea-5366-401a-83f0-2d35e2324aa9 61 fields · synced Aug 1, 2026
- EUDAMED d8cdb641-5bf4-4252-b9e9-68c341b38d37 61 fields · synced Aug 1, 2026
- EUDAMED dbf9a6ff-5032-4aa0-a6f7-baf53bfb689a 61 fields · synced Aug 1, 2026
- EUDAMED c946711b-150b-4eff-8f6a-545e60edde88 61 fields · synced Aug 1, 2026
- EUDAMED 85081acf-ff14-4f4c-9046-17c2eb88b1bd 61 fields · synced Aug 1, 2026