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Plk

EUDAMEDFDA UDI

Class I (EU MDR)

Ref PLK-003Model PLK-002

by Bsl Co. Ltd.

Identity

Trade Name
PLK EUDAMED
Smart Lock FDA UDI
Generic Name
Syringe lock FDA UDI
Device Name
Manual Aspirator EUDAMED
Model / Reference
PLK-002 EUDAMED
PLK-003 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
08800080230029 EUDAMEDFDA UDI
Basic UDI-DI
088000802PLKE2 EUDAMED
Direct Marketing DI
08800080230029 EUDAMED
FDA Product Code
MDM FDA UDI
EMDN Code
Z120105 SURGICAL MEDICAL ASPIRATORS EUDAMED
GMDN Term
Syringe lock FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4800 FDA UDI
Market of Registration
Austria 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Plk by BSL Co., Ltd — Class I — 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
Bsl Co. Ltd.
EUDAMED SRN
KR-MF-000025426
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

  • EUDAMED ed7a3c3b-8e15-4f2c-ac7d-16c0e4067345 61 fields · synced Jun 19, 2026
  • FDA UDI f1c35474-52e2-4d46-8bff-6b852831e9cc 33 fields · synced May 30, 2026