Identity
- Trade Name
- BOISAFE EUDAMED
- Device Name
- Disposable Insulin Syringes EUDAMED
- Model / Reference
- TD-INS-D EUDAMEDTD-INS-D-1ml-U100-0.33mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945632020207 EUDAMED
- Basic UDI-DI
- 69456320INS004MW EUDAMED
- EMDN Code
- A02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Boisafe by Changzhou Tongda Medical Appliance Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69456320INS004MW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Tongda Medical Appliance Co., Ltd.
- EUDAMED SRN
- CN-MF-000027398
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED c69d0cab-4771-4020-8132-1ec81dc852dd 61 fields · synced Oct 6, 2026