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UBTest Breath Bag-BASE LINE and UBTest Breath Bag-SAMPLE
EUDAMEDClass I (EU MDR)
Ref 03536021
Identity
- Device Name
- UBTest Breath Bag-BASE LINE and UBTest Breath Bag-SAMPLE EUDAMED
- Model / Reference
- 03536021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987035647416 EUDAMED
- Basic UDI-DI
- 498703501A1RA3015C EUDAMED
- Direct Marketing DI
- 04987035647416 EUDAMED
- EMDN Code
- A060399 FLUID COLLECTION BAGS AND SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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: General-purpose suction system, pneumatic
UBTest Breath Bag-BASE LINE and UBTest Breath Bag-SAMPLE by Otsuka Pharmaceutical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 498703501A1RA3015C | Class I | Active |
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Manufacturer
- Manufacturer
- Otsuka Pharmaceutical Co., Ltd.
- EUDAMED SRN
- JP-MF-000025192
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED a9d3c43e-0ec0-405f-ad8d-495c8c6cb7d8 61 fields · synced Jun 19, 2026