Identity
- Trade Name
- NOVAMA EUDAMED
- Device Name
- Nasal Aspirator EUDAMED
- Model / Reference
- DL-BX01, DL-BX02, DL-BX03 EUDAMED471011004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970701961266 EUDAMED
- Basic UDI-DI
- 697070196471011001NU EUDAMED
- EMDN Code
- R05010399 MUCOSITY ASPIRATORS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Novama by Taian Dalu Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697070196471011001NU | Class I | Active |
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Manufacturer
- Manufacturer
- Taian Dalu Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000003009
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED a07abf6d-c956-4b1b-b8e2-1a9a84d78346 61 fields · synced Jun 18, 2026