← Back to catalogue
Disposable Pressure Bandage
EUDAMEDClass I (EU MDR)
Ref OM-TB04-03Ref OM-TB04-02
Identity
- Trade Name
- Disposable Pressure Bandage EUDAMED
- Device Name
- Disposable Pressure Bandage EUDAMED
- Model / Reference
- OM-TB04-03 EUDAMEDOM-TB04-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985351313 EUDAMED06972985351306 EUDAMED
- Basic UDI-DI
- B-06972985351313 EUDAMEDB-06972985351306 EUDAMED
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) 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 Pressure Bandage 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-06972985351313 | 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 (2)
- EUDAMED 1d63ba1d-2858-4090-8853-5e28de1dfacf 61 fields · synced Jul 14, 2026
- EUDAMED a4663104-a358-4fa2-ada1-fbbf84b23f16 61 fields · synced May 16, 2026