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Ergoline/PASSION PLUS 40/3 Smart Performance - PF

FDA UDI

Class II (US FDA UDI)

by JK-Products GmbH

Identity

Trade Name
Ergoline/PASSION PLUS 40/3 Smart Performance - PF FDA UDI
Generic Name
Ultraviolet tanning device FDA UDI
Model / Reference
JK 103 / 40-3 AC FDA UDI

Identifiers

Primary DI / UDI-DI
EJKP10000100003599A0 FDA UDI
510(k) Number
K151400 FDA UDI
FDA Product Code
LEJ FDA UDI
GMDN Term
Ultraviolet tanning device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4635 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Ergoline/PASSION PLUS 40/3 Smart Performance - PF by JK-Products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151400 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
JK-Products GmbH

Sources (1)

  • FDA UDI b0082860-bf7c-400e-9d92-5dbf13903f7e 34 fields · synced May 30, 2026