Identity
- Device Name
- Capsule Surveillance EUDAMED
- Model / Reference
- TBD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03615041990431 EUDAMED
- Basic UDI-DI
- 0884838BM1118LZ EUDAMED
- EMDN Code
- Z1203020292 MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIb 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
Capsule Surveillance by Philips North America LLC — Class IIb — 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 | 0884838BM1118LZ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips North America LLC
- EUDAMED SRN
- US-MF-000033010
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (1)
- EUDAMED 6f0de35a-c3c5-41b9-94b7-ee3d7a2fc908 61 fields · synced Jun 20, 2026