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Hex Driver_ Ratchet Type

EUDAMEDFDA UDI

Class I (EU MDR)

Ref HD1220

by Neobiotech Co., Ltd.

Identity

Trade Name
Hex Driver_ Ratchet Type EUDAMED
Neobiotech Implant System FDA UDI
Generic Name
Dental implant system FDA UDI
Device Name
Dental Surgical Instrument EUDAMED
1.2Hex, L:20.0mm FDA UDI
Model / Reference
HD1220 EUDAMEDFDA UDI
Description
1.2Hex, L:20.0mm FDA UDI

Identifiers

Primary DI / UDI-DI
08809276768636 EUDAMEDFDA UDI
Basic UDI-DI
880927676NBRSIRSCL1S03FT EUDAMED
FDA Product Code
NDP FDA UDI
EMDN Code
P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
GMDN Term
Dental implant system FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.3980 FDA UDI
Market of Registration
Poland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Introducing the Hex Driver Ratchet Type, a precision dental surgical instrument designed for high-precision procedures. This advanced tool features a unique hex driver ratchet mechanism, ensuring accurate and consistent results. The Hex Driver Ratchet Type is available for purchase online at [Your Website URL] and is compliant with regulatory standards set by organizations such as FDA and ISO 13485.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neobiotech Co., Ltd.
EUDAMED SRN
KR-MF-000016946
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (2)

  • EUDAMED 6f6a409e-f94e-429c-91ef-d349201f67c1 61 fields · synced Jul 22, 2026
  • FDA UDI 1d2cfe25-5262-4fde-a012-fb7dc0bef8fe 33 fields · synced May 30, 2026