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iTOOL
EUDAMEDClass IIa (EU MDR)
Ref 201-04-00Ref 201-00-44Ref 201-00-46Ref 201-00-50Ref 201-00-52Ref 201-00-51Ref 201-05-00Ref 201-02-00
Identity
- Trade Name
- iTOOL EUDAMED
- Device Name
- Disposable Pulse Lavage EUDAMEDDisposable Lavage Tips EUDAMEDDisposable Lavage Tip EUDAMED
- Model / Reference
- 201-04-00 EUDAMED201-00-44 EUDAMED201-00-46 EUDAMED201-00-50 EUDAMED201-00-52 EUDAMED201-00-51 EUDAMED201-05-00 EUDAMED201-02-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972130470033 EUDAMED16972130470064 EUDAMED16972130470071 EUDAMED16972130470088 EUDAMED16972130470101 EUDAMED16972130470095 EUDAMED16972130470040 EUDAMED16972130470019 EUDAMED
- Basic UDI-DI
- B-16972130470033 EUDAMEDB-16972130470064 EUDAMEDB-16972130470071 EUDAMEDB-16972130470088 EUDAMEDB-16972130470101 EUDAMEDB-16972130470095 EUDAMEDB-16972130470040 EUDAMEDB-16972130470019 EUDAMED
- EMDN Code
- A03040299 IRRIGATION KITS, SINGLE-USE - OTHER EUDAMEDA0380 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-16972130470033 | 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 (8)
- EUDAMED f9e32b59-4e1a-4855-b977-b9de98a88678 61 fields · synced Oct 6, 2026
- EUDAMED 2369a09f-1222-4944-a810-9ca1f8ae97a6 61 fields · synced May 16, 2026
- EUDAMED 6422719c-2c98-4911-98e8-dbfcb321891f 61 fields · synced May 17, 2026
- EUDAMED a774f142-fe9a-409b-9cd4-dc3e682d730b 61 fields · synced May 17, 2026
- EUDAMED 9093afc4-25cc-45fb-ab98-bcbfba47c606 61 fields · synced May 17, 2026
- EUDAMED b5197520-815a-4664-9147-faaf76f35dbb 61 fields · synced May 17, 2026
- EUDAMED c9c59eae-e4c4-4f1e-9891-f94913d8eafd 61 fields · synced May 19, 2026
- EUDAMED ba009f56-943d-42a8-8a77-fb1e74a53df7 61 fields · synced May 19, 2026