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Disposable Inflation Devices
EUDAMEDClass I (EU MDR)
Ref OM-ID-012002Ref OM-ID-022004Ref OM-ID-022002Ref OM-ID-022003Ref OM-ID-012004
Identity
- Trade Name
- Disposable Inflation Devices EUDAMED
- Device Name
- Disposable Inflation Devices EUDAMED
- Model / Reference
- OM-ID-012002 EUDAMEDOM-ID-022004 EUDAMEDOM-ID-022002 EUDAMEDOM-ID-022003 EUDAMEDOM-ID-012004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985350255 EUDAMED06972985350316 EUDAMED06972985350293 EUDAMED06972985350309 EUDAMED06972985350279 EUDAMED
- Basic UDI-DI
- B-06972985350255 EUDAMEDB-06972985350316 EUDAMEDB-06972985350293 EUDAMEDB-06972985350309 EUDAMEDB-06972985350279 EUDAMED
- EMDN Code
- C010401020180 PTCA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Disposable Inflation Devices by Ortus Medi-Tech Co., Ltd — Class I — 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-06972985350255 | Class I | Active |
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Manufacturer
- Manufacturer
- Ortus Medi-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000031033
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED bd40eea6-b1a8-42ff-a429-86763398868f 61 fields · synced Aug 3, 2026
- EUDAMED 03962ecf-96e9-4365-9a80-68996d8bae58 61 fields · synced May 17, 2026
- EUDAMED 76e56bc1-eb0b-44bc-aded-773dbc62f289 61 fields · synced May 18, 2026
- EUDAMED 79fef0eb-d0f6-423c-9f91-ebb538739894 61 fields · synced May 18, 2026
- EUDAMED 04d47deb-03d0-4d20-9b49-328e9ac7d8de 61 fields · synced May 19, 2026