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Monitoring set, single
EUDAMEDClass IIb (EU MDR)
Ref 74.4282Model Xtrans® / DPT-6000 , ABSS
Identity
- Trade Name
- Monitoring set, single EUDAMED
- Device Name
- Invasive Pressure Monitoring Set EUDAMED
- Model / Reference
- Xtrans® / DPT-6000 , ABSS EUDAMED74.4282 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04046765094065 EUDAMED
- Basic UDI-DI
- 4046765ABSXABR8 EUDAMED
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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: In-line arterial blood sampling set
Monitoring set, single by CODAN pvb Critical Care GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as In-line arterial blood sampling set.
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- Disposable Pressure Transducer — ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. · Class IIb
- ICU Medical — ICU MEDICAL, INC. · Class II
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 | 4046765ABSXABR8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- CODAN pvb Critical Care GmbH
- EUDAMED SRN
- DE-MF-000007510
Sources (1)
- EUDAMED 02358ede-cc37-4b60-845c-c4eaaa4aa626 61 fields · synced Jul 15, 2026