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Sunmed™ Haemostatic valves
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SM-HV-7PFLCW-TBRef SM-HV-7CFLCR-TBRef SM-HV-8SPLCR-TBRef SM-HV-7PF-TBRef SM-HV-7CPLPW-TBRef SM-TD-CW-MPRef SM-HV-10PSF-TBRef SM-HV-8WFLCR-TBRef SM-HV-8SFLPR-TBRef SM-HV-9SPLCR-TBRef SM-HV-8SFLPW-TBRef SM-HV-7PFLCR-TBRef SM-HV-7CFLPW-TBRef SM-HV-7PP-TBRef SM-HV-7PPLPW-TBRef SM-HV-8CPLPW-TBRef SM-HV-7APHF-TBRef SM-HV-7CF-TBRef SM-HV-7APHFLCR-TB
Identity
- Trade Name
- Sunmed™ Haemostatic valves EUDAMEDSunmed Haemostatic Valves FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- Haemostatic valves EUDAMED
- Model / Reference
- SM-HV-7PFLCW-TB EUDAMEDSM-HV-7CFLCR-TB EUDAMEDSM-HV-8SPLCR-TB EUDAMEDSM-HV-7PF-TB EUDAMEDSM-HV-7CPLPW-TB EUDAMEDSM-TD-CW-MP EUDAMEDSM-HV-10PSF-TB EUDAMEDSM-HV-8WFLCR-TB EUDAMEDSM-HV-8SFLPR-TB EUDAMEDSM-HV-9SPLCR-TB EUDAMEDSM-HV-8SFLPW-TB EUDAMEDSM-HV-7PFLCR-TB EUDAMEDSM-HV-7CFLPW-TB EUDAMEDSM-HV-7PP-TB EUDAMEDSM-HV-7PPLPW-TB EUDAMEDSM-HV-8CPLPW-TB EUDAMEDSM-HV-7APHF-TB EUDAMEDSM-HV-7CF-TB EUDAMEDSM-HV-7APHFLCR-TB EUDAMED7F, Push-pull, Sideon Tubing and Stopcock, Insertion Tool, Torquer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947358540762 EUDAMED06947358543732 EUDAMED06947358543855 EUDAMED06947358541745 EUDAMED06947358546726 EUDAMED06947358544401 EUDAMED06947358543121 EUDAMED06947358548812 EUDAMED06947358540502 EUDAMED06947358543916 EUDAMED06947358543824 EUDAMED06947358543794 EUDAMED06947358546764 EUDAMED06947358541738 EUDAMED06947358546719 EUDAMEDFDA UDI06947358546849 EUDAMED06947358540700 EUDAMED06947358541769 EUDAMED06947358543206 EUDAMED
- Basic UDI-DI
- 694735850004LB EUDAMED
- FDA Product Code
- DTL FDA UDIDQX FDA UDI
- EMDN Code
- C0104010280 INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4290 FDA UDI870.1330 FDA UDI
- Market of Registration
- Czechia EUDAMEDBulgaria EUDAMEDAustria EUDAMEDPoland EUDAMEDItaly EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sunmed™ Haemostatic valves by Sunny Medical Device (Shenzhen) Co.Ltd — Class IIa — 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 | 694735850004LB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sunny Medical Device (Shenzhen) Co.Ltd
- EUDAMED SRN
- CN-MF-000022722
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (20)
- EUDAMED a3ca154b-4a7e-4636-ad7e-70e67144ae91 61 fields · synced Sep 18, 2026
- EUDAMED 94ac818e-ade6-4264-abd4-7678d7ea1193 61 fields · synced May 17, 2026
- EUDAMED 434c2dc1-801c-42d0-865f-7ed10b301153 61 fields · synced May 17, 2026
- EUDAMED 1b656922-82d3-4e55-835a-43ccd94a4a13 61 fields · synced May 17, 2026
- EUDAMED 3a01942c-ed6d-4ba3-97f8-1f2a824d79a1 61 fields · synced May 17, 2026
- EUDAMED 6813b2fa-8347-494c-a301-f1946f8c88bd 61 fields · synced May 17, 2026
- EUDAMED 81934268-ced9-4594-bc21-df5607ae2dbe 61 fields · synced May 17, 2026
- EUDAMED aa8dbc76-0418-4450-9108-3428a2d1d460 61 fields · synced May 17, 2026
- EUDAMED d6b84b10-9adb-47f8-a0f5-e73709a4694b 61 fields · synced May 18, 2026
- EUDAMED 41ddd9fb-ed43-46b2-8858-e0d02b5cc606 61 fields · synced May 18, 2026
- EUDAMED 75c81167-8565-41ae-a61d-b34cbbbf4547 61 fields · synced May 18, 2026
- EUDAMED 37ab7dae-fee6-495c-8dc4-aa5f6d20136a 61 fields · synced May 18, 2026
- EUDAMED ac9cf196-0a1f-4375-845f-5e98e13e94d9 61 fields · synced May 18, 2026
- EUDAMED 82e348cc-a6f0-4c6b-835b-ba55b99c14b2 61 fields · synced May 18, 2026
- EUDAMED fe9246c0-6f62-4b22-8db7-8a36c7ceeff7 61 fields · synced May 18, 2026
- EUDAMED 26084a8a-0931-4281-8ac3-f3f02456d378 61 fields · synced May 18, 2026
- EUDAMED 8562936e-6f58-4df1-b22f-8a246fce84dc 61 fields · synced May 19, 2026
- EUDAMED 2f4a3220-4a50-4140-9a7e-7cb930dc436a 61 fields · synced May 19, 2026
- EUDAMED 1de3d36c-e214-45b8-9e4b-5c1c56b79752 61 fields · synced May 19, 2026
- FDA UDI 434e6052-9345-4a72-a136-8aa6ef15bb4c 32 fields · synced May 30, 2026