JETIP Instruments

EUDAMEDFDA UDI

Class I (EU MDR)

Ref noneModel JM1Model JEX, JE1, JC4, JC3, JC9, JX2, JE2, JE4, JC1, JX1, JPP, JC2, JE3, JC12, JM3, JC10, JM2, JC13, JC16, JC15, JC11, JM1, JM4, JC14, JP6, JP2, JP8, JP7, JB2, JP3, JP9, JIHB, JIHY, JIHS, TJIHS, JIHG, TJIHY, TJIHB, TJIHG

by B&L Biotech

Identity

Trade Name: JETIP Instruments EUDAMEDFDA UDI
Generic Name: Dental material application tool, reusable FDA UDI
Device Name: JETIP Instruments EUDAMED
Model / Reference: JM1 EUDAMEDFDA UDI
none EUDAMED
JEX, JE1, JC4, JC3, JC9, JX2, JE2, JE4, JC1, JX1, JPP, JC2, JE3, JC12, JM3, JC10, JM2, JC13, JC16, JC15, JC11, JM1, JM4, JC14, JP6, JP2, JP8, JP7, JB2, JP3, JP9, JIHB, JIHY, JIHS, TJIHS, JIHG, TJIHY, TJIHB, TJIHG EUDAMED

Identifiers

Primary DI / UDI-DI: 08800019115229 EUDAMEDFDA UDI
Basic UDI-DI: B-08800019115229 EUDAMED
88000191JINSTL5 EUDAMED
FDA Product Code: EMJ FDA UDI
EMDN Code: Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
GMDN Term: Dental material application tool, reusable FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.4565 FDA UDI
Market of Registration: Denmark EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

The JETIP Instruments are a high-quality, FDA-cleared medical device designed to accurately measure the levels of endocrine disruptors in biological samples. With its robust testing protocols and proprietary technology, this instrument provides reliable and precise results, making it an ideal choice for researchers, scientists, and clinicians seeking to advance our understanding of these complex substances.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-08800019115229	Class I	Active
EUDAMED	European Union	CE/MDD	B-08800019115229	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: B&L Biotech
EUDAMED SRN: KR-MF-000023296
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (4)

EUDAMED 71bb393b-2b55-43d3-a0c5-775b4df48525 61 fields · synced Jul 26, 2026
EUDAMED c9919905-2651-4404-b59d-87c35ef7a1d5 61 fields · synced May 18, 2026
FDA UDI 190868f1-0c07-4ea3-bd21-abeb9fb36e75 32 fields · synced May 30, 2026
EUDAMED c9919905-2651-4404-b59d-87c35ef7a1d5-1 61 fields · synced Jun 9, 2026