Identity
- Trade Name
- Sentinelle Biopsy Grid [package] EUDAMED
- Device Name
- Breast Biopsy Guidance Devices EUDAMED
- Model / Reference
- 989603216901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10884838103747 EUDAMED
- Basic UDI-DI
- 0884838BM421SN EUDAMED
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Sentinelle Biopsy Grid [package] by Invivo Corporation — 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 | 0884838BM421SN | Class I | Active |
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Manufacturer
- Manufacturer
- Invivo Corporation
- EUDAMED SRN
- US-MF-000002284
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (1)
- EUDAMED 43235bb8-b9f0-4c79-bde4-c5ae1bcdc03c 61 fields · synced Jun 20, 2026