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CBL 3 Leadset, Grabber, AAMI, ICU

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 989803145091

by Philips Medizin Systeme Böblingen GmbH

Identity

Trade Name
CBL 3 Leadset, Grabber, AAMI, ICU EUDAMED
ECG Cables and Leadsets FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Device Name
ECG Lead Sets EUDAMED
3 Leadset, Grabber, AAMI, ICU FDA UDI
Model / Reference
989803145091 EUDAMED
CBL 3 Leadset, Grabber, AAMI, ICU FDA UDI
Description
3 Leadset, Grabber, AAMI, ICU FDA UDI

Identifiers

Catalog Number
989803145091 FDA UDI
Primary DI / UDI-DI
00884838021303 EUDAMEDFDA UDI
Basic UDI-DI
0884838BM556TE EUDAMED
FDA Product Code
IKD FDA UDI
EMDN Code
Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
GMDN Term
Electrocardiographic lead set, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
890.1175 FDA UDI
Market of Registration
Austria 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

CBL 3 Leadset, Grabber, AAMI, ICU by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medizin Systeme Böblingen GmbH
EUDAMED SRN
DE-MF-000006026

Sources (2)

  • EUDAMED 5b597f2f-578c-41b2-946f-8bc82e920675 61 fields · synced Jul 14, 2026
  • FDA UDI 6d4a3862-663d-445c-8e47-4cf8bb8c06c3 36 fields · synced May 30, 2026