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Mini Locking Plate

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 021020008

by Double Medical Technology Inc.

Identity

Trade Name
2.0S-LCP-Plate FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name
Mini Locking Plate EUDAMED
Model / Reference
021020008 EUDAMEDFDA UDI

Identifiers

Catalog Number
021020008 FDA UDI
Primary DI / UDI-DI
06942782477042 EUDAMEDFDA UDI
Basic UDI-DI
6902139CS03001AP EUDAMED
Direct Marketing DI
06942782477042 EUDAMED
510(k) Number
K130108 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
EMDN Code
P09120501 OSTEOSYNTHESIS COMPRESSION PLATES EUDAMED
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Market of Registration
Croatia EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

Yes

EUDAMED

Sutures

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Width — 5.0 Millimeter FDA UDI
Length — 59.0 Millimeter FDA UDI

Mini Locking Plate by Double Medical Technology 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
Double Medical Technology Inc.
EUDAMED SRN
CN-MF-000009048
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 3f709edc-0cf1-42d8-8025-5ac245f735a2 61 fields · synced Jun 18, 2026
  • FDA UDI 9c556d8d-9074-4e1b-b395-6db6f82c0383 36 fields · synced May 25, 2026