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Dalim Medical Corp.

Active in EUDAMED

South Koreafrom SRN EUDAMED FDA SRN KR-MF-000019876 FEI 3020347456

Devices
35
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI

What Dalim Medical Corp. makes

Dalim Medical Corp. manufactures the Uni-port, a single-port laparoscopic surgical system designed for minimally invasive procedures.

The Uni-port is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue35

Newest first, rows 1-35 of 35

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  • Uni-port Ref UP01FV2-D

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP01F

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03FV2-B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03FV2SP-B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03FLV2-F

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FSP-B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FV2SP-A

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03FL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Eagle-port Ref EP05F150

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Eagle-port Ref EP12F150

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP01FL

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Eagle-port Ref EP05F075

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FLV2-F

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FV2-B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04F

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03F

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FSP-A

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03FV2SP

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Eagle-port Ref EP10F100

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03FV2SP-A

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Eagle-port Ref EP05F110

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Eagle-port Ref EP12F100

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FSP

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03FSV2SP-A

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FV2SP-B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP01FLV2-D

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Eagle-port Ref EP10F150

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FSP-C

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FLV2-B

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03FV2-F

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FV2SP

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP03FSV2SP

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref UP04FV2-F

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Uni-port Ref K232062

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-35 of 35

Company details

EUDAMED SRN
KR-MF-000019876
FDA FEI number
3020347456
EUDAMED status
Active
EUDAMED registered name
Dalim Medical corp.
Registered address
397, Seokcheon-ro, 14449, Bucheon-si, Gyeonggi-do, South Korea
PRRC contact
Jihoon Eom(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 13 Aug 2031

EUDAMED certificates (1)

Notified body 2975 1 certificate

  • 2975-MED-2622601 Active

    Quality management system EU MDR

    Issued
    14 Aug 2026
    Expires
    13 Aug 2031

Frequently asked questions

How many devices does Dalim Medical Corp. have in the registry?

The registry currently lists 35 devices for Dalim Medical Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dalim Medical Corp.'s devices?

Among its 35 most recently registered devices, Dalim Medical Corp. has devices listed in EUDAMED (34 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Dalim Medical Corp.'s devices fall under?

Among its 35 most recently registered devices, the classes recorded for Dalim Medical Corp.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Dalim Medical Corp.?

EUDAMED lists 1 certificate for Dalim Medical Corp. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-08-14.

What are the newest devices from Dalim Medical Corp. in the registry?

The most recently registered devices listed for Dalim Medical Corp. include Uni-port and Eagle-port.

Generated automatically from registry data and not verified by a human reviewer.