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INNO Implant System

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref SR3310NS

by Cowellmedi Co., Ltd.

Identity

Trade Name
INNO Implant System EUDAMED
INNO SLA Submerged Narrow Implant System-Pre-Mount Type Fixture FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
INNO Sub. Fixture EUDAMED
Model / Reference
SR3310NS EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08809471729784 EUDAMEDFDA UDI
Basic UDI-DI
B-08809471729784 EUDAMED
510(k) Number
K231395 FDA UDI
FDA Product Code
DZE FDA UDI
EMDN Code
P01020101 DENTAL IMPLANTS EUDAMED
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

INNO Implant System by Cowellmedi Co., Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cowellmedi Co., Ltd.
EUDAMED SRN
KR-MF-000009689
Authorised Representative
AR Experts B.V. NL-AR-000023989

Sources (2)

  • EUDAMED e0a417e0-feca-4323-ae87-6e15cf231185 61 fields · synced Jun 8, 2026
  • FDA UDI 513162ac-998d-4aca-b119-a2ce26f264c9 33 fields · synced May 30, 2026