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Puncture Needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 271001Model 18GModel 18G, 20G, 21G, 22G
Identity
- Trade Name
- Puncture needle FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- Puncture Needle EUDAMEDNeedle EUDAMED
- Model / Reference
- 18G EUDAMEDFDA UDI271001 EUDAMED18G, 20G, 21G, 22G EUDAMED
Identifiers
- Catalog Number
- 271001 FDA UDI
- Primary DI / UDI-DI
- 06971162818076 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971162818076 EUDAMED697116281NE27FW EUDAMED
- FDA Product Code
- DRC FDA UDI
- EMDN Code
- A019013 PERCUTANEOUS NEEDLES EUDAMED
- GMDN Term
- Vascular catheter introduction needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1390 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
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
Puncture Needle by Tianck Medical Co., Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06971162818076 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971162818076 | 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 (3)
- EUDAMED 6d1d7d2d-d9d8-4803-b4b0-c4b97c4458b4 61 fields · synced Oct 6, 2026
- EUDAMED 5e2011e3-84ec-4eda-a744-154d6ed58b1e 61 fields · synced May 18, 2026
- FDA UDI 52ffa98b-8ba5-4a9c-bcd7-02d42fc2d448 33 fields · synced May 30, 2026