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8Ch Medial Coil Sen 3T

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 300006546171

by Philips Medical Systems Nederland B.V.

Identity

Trade Name
8Ch Medial Coil Sen 3T EUDAMED
DUNLEE SENTINELLE FDA UDI
Generic Name
MRI system coil, radio-frequency FDA UDI
Device Name
Siemens Breast Coil PMS EUDAMED
Medial Array Coil VS 16Ch FDA UDI
Model / Reference
300006546171 EUDAMED
8Ch Medial Coil Sen 3T FDA UDI
Description
Medial Array Coil VS 16Ch FDA UDI

Identifiers

Catalog Number
300006546171 FDA UDI
Primary DI / UDI-DI
00884838109766 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM909TR EUDAMED
Direct Marketing DI
00884838109766 EUDAMED
510(k) Number
K112112 FDA UDI
FDA Product Code
MOS FDA UDI
EMDN Code
Z1105018001,Z1105018002,Z1105018099 EUDAMED
GMDN Term
MRI system coil, radio-frequency FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

8Ch Medial Coil Sen 3T by Philips Medical Systems Nederland B.V. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medical Systems Nederland B.V.
EUDAMED SRN
NL-MF-000001489

Sources (2)

  • EUDAMED c7151d14-68bc-42d6-874e-032fa0473b2e 61 fields · synced Oct 6, 2026
  • FDA UDI cb13e80d-ec3b-4441-ab2f-1dfdbd2dc7e1 37 fields · synced May 29, 2026