Identity
- Trade Name
- ORNEX + MED-STOP EUDAMED
- Device Name
- Non-sterile Suction tubing and connectors EUDAMED
- Model / Reference
- ORNEX66VCA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10888277425132 EUDAMED
- Basic UDI-DI
- 0888277DC300NSJ7 EUDAMED
- EMDN Code
- A060102 SURGICAL DRAINAGE CONNECTION MEDICAL TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Suction/irrigation tubing, single-use
Ornex + Med-Stop by Medline Industries, LP — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Suction/irrigation tubing, single-use.
- Non-sterile aspiration tubes — Produtos Médicos Hospitalares, SA · Class I
- AMSure® Suction Connecting Tube with Pre-Attached Yankauer — AMSINO INTERNATIONAL, INC. · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- ENT-single-use suction tubes, angled — Spiggle & Theis Medizintechnik GmbH · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Conneting tube — Grena (Qingdao) Medical Devices Ltd. · Class I
- Suction Tube Ch 24, 350 cm — Dispo Medical B.V. · Class I
- Bioseal Inc. — BIOSEAL · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0888277DC300NSJ7 | Class I | Active |
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Manufacturer
- Manufacturer
- Medline Industries, LP
- EUDAMED SRN
- US-MF-000009717
- Authorised Representative
- Medline International France FR-AR-000001814
Sources (1)
- EUDAMED 856a2e42-bc12-4f72-81d6-f20950835eaa 61 fields · synced Jul 8, 2026