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Connecting tubes
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 044001Model 10cm with three-way stopcock
Identity
- Trade Name
- Connecting Tube FDA UDI
- Generic Name
- Invasive blood pressure monitoring tubing set FDA UDI
- Device Name
- Connecting tubes EUDAMED
- Model / Reference
- 10cm with three-way stopcock EUDAMEDFDA UDI044001 EUDAMED
Identifiers
- Catalog Number
- 044001 FDA UDI
- Primary DI / UDI-DI
- 06971162810698 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971162810698 EUDAMED
- FDA Product Code
- BYY FDA UDI
- EMDN Code
- A03020102 HIGH PRESSURE EXTENSION LINES EUDAMED
- GMDN Term
- Invasive blood pressure monitoring tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Netherlands 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
Connecting tubes by Tianck Medical Co., Ltd. — Class IIa — 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-06971162810698 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (2)
- EUDAMED 05b6395b-e200-4590-b9ba-f4498f00a12d 61 fields · synced Jul 23, 2026
- FDA UDI 773a767f-d1dd-4d75-8c0a-f5f5be5c1843 33 fields · synced May 30, 2026