← Back to catalogue
Disposable Manifold
EUDAMEDClass I (EU MDR)
Ref OM-MF04-500NRef OM-MF01-500FRef OM-MF03-500FRef OM-MF01-1200NRef OM-MF02-500NRef OM-MF01-1200FRef OM-MF01-500NRef OM-MF02-500F
Identity
- Trade Name
- Disposable Manifold EUDAMED
- Device Name
- Disposable Manifold EUDAMED
- Model / Reference
- OM-MF04-500N EUDAMEDOM-MF01-500F EUDAMEDOM-MF03-500F EUDAMEDOM-MF01-1200N EUDAMEDOM-MF02-500N EUDAMEDOM-MF01-1200F EUDAMEDOM-MF01-500N EUDAMEDOM-MF02-500F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985350569 EUDAMED06972985350491 EUDAMED06972985350552 EUDAMED06972985350507 EUDAMED06972985350521 EUDAMED06972985350514 EUDAMED06972985350484 EUDAMED06972985350538 EUDAMED
- Basic UDI-DI
- B-06972985350569 EUDAMEDB-06972985350491 EUDAMEDB-06972985350552 EUDAMEDB-06972985350507 EUDAMEDB-06972985350521 EUDAMEDB-06972985350514 EUDAMEDB-06972985350484 EUDAMEDB-06972985350538 EUDAMED
- EMDN Code
- A0703 STOPCOCKS 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 Manifold 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-06972985350569 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortus Medi-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000031033
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (8)
- EUDAMED 4b00e719-dac7-4f9d-af76-abdb743fd55a 61 fields · synced Aug 4, 2026
- EUDAMED 214f200d-6380-44ef-8f1e-d57b15ef67be 61 fields · synced May 17, 2026
- EUDAMED 4bef2801-6377-4d02-8d06-2b676e36a8f9 61 fields · synced May 18, 2026
- EUDAMED e62561cc-1293-48e0-97e3-47e239f78007 61 fields · synced May 18, 2026
- EUDAMED 46f1471a-cfbf-4947-8264-a45939de0107 61 fields · synced May 18, 2026
- EUDAMED c03608bc-77ea-4a05-9e39-b9c6eb28a843 61 fields · synced May 18, 2026
- EUDAMED d5231ae1-eec1-4193-9740-a1ece2fc2151 61 fields · synced May 18, 2026
- EUDAMED 6713afc4-59b5-4418-8fbf-62d997aafe5e 61 fields · synced May 19, 2026