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Radial Artery Closure Band
EUDAMEDFDA UDIClass I (EU MDR)
Ref 191004Model TB-03MRef 191005Model TB-03SRef 191003Model TB-03L
Identity
- Trade Name
- Radial artery closure band FDA UDI
- Generic Name
- Radial artery compression device FDA UDI
- Device Name
- Radial Artery Closure Band EUDAMED
- Model / Reference
- TB-03M EUDAMEDFDA UDI191004 EUDAMEDTB-03L EUDAMEDFDA UDITB-03S EUDAMEDFDA UDI191005 EUDAMED191003 EUDAMED
Identifiers
- Catalog Number
- 191004 FDA UDI191003 FDA UDI191005 FDA UDI
- Primary DI / UDI-DI
- 06936841200122 EUDAMEDFDA UDI06971162817451 EUDAMEDFDA UDI06936841200092 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06936841200122 EUDAMEDB-06936841200092 EUDAMEDB-06971162817451 EUDAMED
- FDA Product Code
- KCY FDA UDI
- EMDN Code
- C90010301 HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS) EUDAMED
- GMDN Term
- Radial artery compression device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Market of Registration
- Türkiye 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radial Artery Closure Band by Tianck Medical Co., Ltd. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06936841200122 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000007451
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 3f5bdc31-70bb-4d6b-a477-c96124d860be 61 fields · synced Jul 29, 2026
- FDA UDI 90dc080f-2ffb-4531-9cf1-748c0843ec1f 33 fields · synced May 30, 2026
- FDA UDI d79bbbeb-3a9b-4ad6-aead-ffaf0eda73ee 33 fields · synced May 30, 2026
- FDA UDI d47d60a1-7147-4eec-ae6d-fd69c08de152 33 fields · synced May 30, 2026
- EUDAMED 57fa7eb6-51ca-4e76-a55c-77a5c2476b7c 61 fields · synced Jul 16, 2026
- EUDAMED 44efd693-30f5-4a9a-9119-2817598962a0 61 fields · synced Jul 20, 2026