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Disposable Inflation Device
EUDAMEDClass I (EU MDR)
Ref OM-ID-022001Ref OM-ID-022005
Identity
- Trade Name
- Disposable Inflation Device EUDAMED
- Device Name
- Disposable Inflation Device EUDAMED
- Model / Reference
- OM-ID-022001 EUDAMEDOM-ID-022005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985352372 EUDAMED06972985350286 EUDAMED
- Basic UDI-DI
- B-06972985352372 EUDAMEDB-06972985350286 EUDAMED
- EMDN Code
- C010401020180 PTCA BALLOON DILATATION CATHETERS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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 Device 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-06972985352372 | 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 (2)
- EUDAMED ad0cc6aa-ab05-4853-bee3-51db41d9eaf3 61 fields · synced Jul 13, 2026
- EUDAMED a83cdd57-ed3b-438f-bd6b-58648b32fd20 61 fields · synced May 17, 2026