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SEER 1000 7 Day

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 85102, 85003Model SEER 1000 7 Day510(k) K130785

by GETEMED Medizin- und Informationstechnik AG

Identity

Trade Name
SEER 1000 7 Day EUDAMED
SEER 1000 FDA UDI
Generic Name
Electrocardiographic ambulatory recorder FDA UDI
Device Name
SEER 1000 7 Day EUDAMED
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional. FDA UDI
Model / Reference
SEER 1000 7 Day EUDAMED
85102, 85003 EUDAMED
7 day - UNI FDA UDI
Description
The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional. FDA UDI

Identifiers

Catalog Number
2067634-060 FDA UDI
Primary DI / UDI-DI
04250903200915 EUDAMEDFDA UDI
Basic UDI-DI
B-04250903200915 EUDAMED
FDA Product Code
MWJ FDA UDI
EMDN Code
Z12050403 ECG HOLTER RECORDERS EUDAMED
GMDN Term
Electrocardiographic ambulatory recorder FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.2800 FDA UDI
Market of Registration
Germany 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

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

Yes

FDA UDI

SEER 1000 7 Day by Getemed Medizin- Und Informationstechnik Ag — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
GETEMED Medizin- und Informationstechnik AG
EUDAMED SRN
DE-MF-000012384

Sources (4)

  • EUDAMED 6bcf7eec-dcff-408d-a0ff-64abab48e7ed 85 fields · synced Jul 11, 2026
  • FDA UDI 283fb592-c7fe-40e4-8b5a-71a9caebc2bf 35 fields · synced May 30, 2026
  • EUDAMED 6bcf7eec-dcff-408d-a0ff-64abab48e7ed-1 61 fields · synced Jun 9, 2026
  • FDA 510(k) K130785 1 fields · synced May 18, 2026