Identity
- Trade Name
- iTool EUDAMED
- Device Name
- Disposable Lavage Shield EUDAMED
- Model / Reference
- 201-00-80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972130470118 EUDAMED
- Basic UDI-DI
- B-16972130470118 EUDAMED
- EMDN Code
- A0380 TUBULAR DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iTool by Apex (Suzhou) Medical Products Company — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16972130470118 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Apex (Suzhou) Medical Products Company
- EUDAMED SRN
- CN-MF-000031975
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 9ca33280-826a-4128-b5eb-4df51135a72d 61 fields · synced May 22, 2026