Identity
- Trade Name
- Bifurcated Needle EUDAMED
- Device Name
- Bifurcated Needle EUDAMED
- Model / Reference
- BFN002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934841516250 EUDAMED
- Basic UDI-DI
- 69348415000246U EUDAMED
- Direct Marketing DI
- 06934841516250 EUDAMED
- EMDN Code
- A019099 NEEDLES FOR OTHER PROCEDURES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Bifurcated Needle by Anhui Tiankang Medical Technology Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222385 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69348415000246U | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Tiankang Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000017064
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 16702152-16e5-4686-ac3f-d020443eee63 61 fields · synced Jun 20, 2026
- FDA 510(k) K222385 1 fields · synced May 18, 2026