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Carestation 620 A1

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 1012-9620-000Model Carestation 620 A1, Carestation 650 A1, Carestation 650c A1

by Datex-Ohmeda Inc.

Identity

Trade Name
Carestation 620 A1 EUDAMED
Carestation 620 FDA UDI
Generic Name
Anaesthesia workstation, general-purpose FDA UDI
Device Name
Anesthesia System EUDAMED
Model / Reference
Carestation 620 A1, Carestation 650 A1, Carestation 650c A1 EUDAMED
1012-9620-000 EUDAMED
A1 FDA UDI

Identifiers

Catalog Number
1012-9620-000 FDA UDI
Primary DI / UDI-DI
00840682103985 EUDAMEDFDA UDI
Basic UDI-DI
8406821BUG00168HK EUDAMED
510(k) Number
K151570 FDA UDI
FDA Product Code
BSZ FDA UDI
EMDN Code
Z1203010101 ANAESTHESIA DEVICES EUDAMED
GMDN Term
Anaesthesia workstation, general-purpose FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
868.5160 FDA UDI
Market of Registration
France 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

Yes

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Carestation 620 A1 by Datex-Ohmeda Inc. — Class IIb — 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
Datex-Ohmeda Inc.
EUDAMED SRN
US-MF-000014656
Authorised Representative
GE Medical Systems SCS FR-AR-000000344

Sources (2)

  • EUDAMED 51e2e746-e3cc-4bf9-9feb-fb9f58f7c3d2 61 fields · synced Jun 20, 2026
  • FDA UDI 2e5c3029-a397-4e7d-9517-d73f9ffd0bae 36 fields · synced May 30, 2026