Identity
- Trade Name
- NOVII PATCH (BOX OF 50) EUDAMED
- Device Name
- Novii Patch EUDAMED
- Model / Reference
- 107-PT-004-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 35060433670078 EUDAMED
- Basic UDI-DI
- 8406821BUG00146H9 EUDAMED
- Direct Marketing DI
- 35060433670078 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 50) 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 4e18f70c-d911-48b0-b326-a14d1356aa8c 61 fields · synced Jul 19, 2026