Identity
- Device Name
- Breathing Filter EUDAMED
- Model / Reference
- CKA-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970240894698 EUDAMED
- Basic UDI-DI
- 697024089BFWY EUDAMED
- Direct Marketing DI
- 06970240894698 EUDAMED
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Secretion suction kit
Breathing Filter by Ningbo Luke Medical Devices Co., LTD — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Secretion suction kit.
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- Suction Catheter Kits, Disposable — Dynarex Corp. · Class I
- AirLife™ Mini-Filter/S, Disposable — AirLife Finland Oy · Class IIa
- HITECARE — Ningbo Boya Medical Equipment Co., Ltd · Class IIa
- RespVac™ — CUTTING EDGE HC BRANDS LLC · Class I
- EXMOOR — Exmoor Plastics , Ltd. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Suction Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
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 | 697024089BFWY | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ningbo Luke Medical Devices Co., LTD
- EUDAMED SRN
- CN-MF-000011732
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 15c89ab3-e19b-4472-ad28-b92b7a820947 61 fields · synced Jul 10, 2026