Identity
- Trade Name
- Manifold FDA UDI
- Generic Name
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
- Device Name
- Manifold EUDAMEDRight off 500PSI FDA UDI
- Model / Reference
- M-02 EUDAMEDFDA UDI121002 EUDAMED
- Description
- Right off 500PSI FDA UDI
Identifiers
- Catalog Number
- 121002 FDA UDI
- Primary DI / UDI-DI
- 06971162812081 EUDAMEDFDA UDI
- Basic UDI-DI
- 6971162812MF126P EUDAMED
- FDA Product Code
- DTL FDA UDI
- EMDN Code
- A0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER EUDAMED
- GMDN Term
- Double-lumen haemodialysis catheter, nonimplantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4290 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
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
Manifold by Tianck Medical 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 | 6971162812MF126P | 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 94070313-d895-47ba-ab73-c74c980f5ffa 61 fields · synced Oct 6, 2026
- FDA UDI 3a918ffa-d6b6-469a-ab81-03415f3180c1 34 fields · synced May 29, 2026