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Safety Insulin Syringes with Retractable Needles
EUDAMEDClass IIa (EU MDR)
Ref TKSIS10001-001-3208Model TKSISRef TKSIS10001-009-3008
Identity
- Trade Name
- Safety Insulin Syringes with Retractable Needles EUDAMED
- Device Name
- Safety Insulin Syringes with Retractable Needles EUDAMED
- Model / Reference
- TKSIS EUDAMEDTKSIS10001-001-3208 EUDAMEDTKSIS10001-009-3008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934841522145 EUDAMED06934841502178 EUDAMED
- Basic UDI-DI
- 69348415000416U EUDAMED
- Direct Marketing DI
- 06934841522145 EUDAMED06934841502178 EUDAMED
- EMDN Code
- A0201060301 INSULIN SYRINGES WITH SAFETY SYSTEMS AND FIXED NEEDLES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
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
Safety Insulin Syringes with Retractable Needles by Anhui Tiankang Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69348415000416U | Class IIa | 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 0431a393-200b-4da1-a14b-175769bbce05 61 fields · synced Oct 6, 2026
- EUDAMED 3d856e01-44a4-451b-8fad-821f131ceea6 61 fields · synced May 18, 2026