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Plk
EUDAMEDClass I (EU MDR)
Ref PLK-005Model PLK-002Ref PLK-004
by Bsl Co. Ltd.
Identity
- Trade Name
- PLK EUDAMED
- Device Name
- Manual Aspirator EUDAMED
- Model / Reference
- PLK-002 EUDAMEDPLK-005 EUDAMEDPLK-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800080230050 EUDAMED08800080230036 EUDAMED08800080230012 EUDAMED
- Basic UDI-DI
- 088000802PLKE2 EUDAMED
- Direct Marketing DI
- 08800080230050 EUDAMED08800080230036 EUDAMED08800080230012 EUDAMED
- EMDN Code
- Z120105 SURGICAL MEDICAL ASPIRATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Plk by BSL Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 088000802PLKE2 | Class I | Active |
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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 (3)
- EUDAMED 1d003e47-fd5a-45c7-8c61-0a745ec811b4 61 fields · synced Aug 3, 2026
- EUDAMED c6ec8efe-1693-4dd9-a2b9-ed5654d16fbd 61 fields · synced May 17, 2026
- EUDAMED fdbed554-2eac-4981-a87d-c35fb8ad39fa 61 fields · synced May 17, 2026