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Disposable Tuberculin Syringe
EUDAMEDClass IIa (EU MDR)
Ref TB01Model 1ml 0.5ml
Identity
- Trade Name
- Disposable Tuberculin Syringe EUDAMED
- Device Name
- Disposable Tuberculin Syringes EUDAMED
- Model / Reference
- 1ml 0.5ml EUDAMEDTB01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971603580002 EUDAMED
- Basic UDI-DI
- 697160358WDTSQ9 EUDAMED
- EMDN Code
- A020109 TUBERCULIN SYRINGES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Disposable Tuberculin Syringe by Shantou Wealy Medical Instrument 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 | 697160358WDTSQ9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shantou Wealy Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000020619
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 3899e8a6-36f3-4a6d-8929-3a335970b773 61 fields · synced Oct 6, 2026