Identity
- Trade Name
- NIBP Cuff EUDAMED
- Device Name
- cuff EUDAMEDNIBP Cuff EUDAMED
- Model / Reference
- IGN0057 EUDAMEDI Series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945040105923 EUDAMED
- Basic UDI-DI
- 69450401IGN-NKH EUDAMED69450401IGNYH EUDAMED
- Direct Marketing DI
- 06945040105923 EUDAMED
- EMDN Code
- R01030202 ENDOTRACHEAL TUBES, CUFFED, REINFORCED EUDAMEDZ12040180 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Reinforced endotracheal tube, single-use
cuff by Contec Medical Systems Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Reinforced endotracheal tube, single-use.
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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 | 69450401IGN-NKH | Class I | Active |
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Manufacturer
- Manufacturer
- Contec Medical Systems Co., Ltd.
- EUDAMED SRN
- CN-MF-000007715
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 1dc834f8-8d90-40d6-863b-5c30c023c066 61 fields · synced Aug 4, 2026
- EUDAMED 9a94c795-fc04-4ef6-87b1-a0243bed42d2 61 fields · synced Aug 4, 2026