Identity
- Trade Name
- NOVII PATCH (BOX OF 10) EUDAMED
- Device Name
- Novii Patch EUDAMED
- Model / Reference
- 107-PT-004-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 25060433670071 EUDAMED
- Basic UDI-DI
- 8406821BUG00146H9 EUDAMED
- Direct Marketing DI
- 25060433670071 EUDAMED
- EMDN Code
- Z1208010485 CARDIOTOCOGRAPHIC TELEMETRY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Novii Patch (box Of 10) by Datex-Ohmeda Inc. — 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 | 8406821BUG00146H9 | Class I | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000002206
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED 65be74ae-c94e-4ee6-ac04-1d85ca893197 61 fields · synced Jul 29, 2026