Manual Resuscitator

EUDAMED

Class IIa (EU MDR)

Ref PMRA03LModel PVCRef SMRA01MModel SiliconeRef PMRA03SRef PMRA04MRef PMRA02LRef SMRA02MRef SMRA02LRef PMRA04SRef SMRB01SRef SMRB02MRef SMRA03LRef SMRB03SRef SMRB04MRef PMRB02MRef PMRB02SRef SMRA01SRef PMRA02SRef SMRA01LRef PMRA01LRef SMRA04LRef PMRA01MRef SMRB04SRef PMRB03SRef PMRB01LRef PMRB01MRef PMRB01SRef SMRA03MRef SMRA02SRef SMRB02SRef SMRA04SRef SMRB03LRef SMRB04L

by Ningbo Luke Medical Devices Co., LTD

Identity

Trade Name: Luke Manual Resuscitator EUDAMED
Device Name: Manual Resuscitator EUDAMED
Model / Reference: PVC EUDAMED
PMRA03L EUDAMED
Silicone EUDAMED
SMRA01M EUDAMED
PMRA03S EUDAMED
PMRA04M EUDAMED
PMRA02L EUDAMED
SMRA02M EUDAMED
SMRA02L EUDAMED
PMRA04S EUDAMED
SMRB01S EUDAMED
SMRB02M EUDAMED
SMRA03L EUDAMED
SMRB03S EUDAMED
SMRB04M EUDAMED
PMRB02M EUDAMED
PMRB02S EUDAMED
SMRA01S EUDAMED
PMRA02S EUDAMED
SMRA01L EUDAMED
PMRA01L EUDAMED
SMRA04L EUDAMED
PMRA01M EUDAMED
SMRB04S EUDAMED
PMRB03S EUDAMED
PMRB01L EUDAMED
PMRB01M EUDAMED
PMRB01S EUDAMED
SMRA03M EUDAMED
SMRA02S EUDAMED
SMRB02S EUDAMED
SMRA04S EUDAMED
SMRB03L EUDAMED
SMRB04L EUDAMED

Identifiers

Primary DI / UDI-DI: 26970240892261 EUDAMED
06970240895046 EUDAMED
06970240894537 EUDAMED
06970240899518 EUDAMED
06970240895428 EUDAMED
06970240892281 EUDAMED
06970240899624 EUDAMED
06970240899617 EUDAMED
06970240895411 EUDAMED
06970240899693 EUDAMED
06970240899716 EUDAMED
06970240894186 EUDAMED
06970240899754 EUDAMED
06970240899778 EUDAMED
06970240899532 EUDAMED
06970240899549 EUDAMED
06970240894926 EUDAMED
06970240898962 EUDAMED
06970240894544 EUDAMED
06970240894513 EUDAMED
06970240894919 EUDAMED
06970240899648 EUDAMED
06970240894506 EUDAMED
06970240899785 EUDAMED
06970240899570 EUDAMED
06970240894940 EUDAMED
06970240894858 EUDAMED
06970240894766 EUDAMED
06970240894193 EUDAMED
06970240899631 EUDAMED
06970240899723 EUDAMED
06970240899662 EUDAMED
06970240894520 EUDAMED
06970240899730 EUDAMED
06970240899761 EUDAMED
06970240894834 EUDAMED
06970240895473 EUDAMED
Basic UDI-DI: 697024089PMRRW EUDAMED
697024089MRYR EUDAMED
Direct Marketing DI: 26970240892261 EUDAMED
06970240895046 EUDAMED
06970240894537 EUDAMED
06970240899518 EUDAMED
06970240895428 EUDAMED
06970240892281 EUDAMED
06970240899624 EUDAMED
06970240899617 EUDAMED
06970240895411 EUDAMED
06970240899693 EUDAMED
06970240899716 EUDAMED
06970240894186 EUDAMED
06970240899754 EUDAMED
06970240899778 EUDAMED
06970240899532 EUDAMED
06970240899549 EUDAMED
06970240894926 EUDAMED
06970240898962 EUDAMED
06970240894544 EUDAMED
06970240894513 EUDAMED
06970240894919 EUDAMED
06970240899648 EUDAMED
06970240894506 EUDAMED
06970240899785 EUDAMED
06970240899570 EUDAMED
06970240894940 EUDAMED
06970240894858 EUDAMED
06970240894766 EUDAMED
06970240894193 EUDAMED
06970240899631 EUDAMED
06970240899723 EUDAMED
06970240899662 EUDAMED
06970240894520 EUDAMED
06970240899730 EUDAMED
06970240899761 EUDAMED
06970240894834 EUDAMED
06970240895473 EUDAMED
EMDN Code: R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Romania EUDAMED
Poland EUDAMED
Türkiye EUDAMED
Greece EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

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

Category: Pulmonary resuscitator, manual, single-use

Manual Resuscitator by Ningbo Luke Medical Devices Co., LTD — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Pulmonary resuscitator, manual, single-use.

Ventlab — Ventlab Corp. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
VT Sure — Pulmodyne Inc. · Class II
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
Ventlab — Ventlab Corp. · Class I
Ventlab — Ventlab Corp. · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II

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	697024089PMRRW	Class IIa	Active

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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 (37)

EUDAMED 28e4c98e-9287-4090-af07-e65110ad7eaa 61 fields · synced Oct 7, 2026
EUDAMED 7343c284-eefb-4c89-a665-c954998dcd1d 61 fields · synced Jun 18, 2026
EUDAMED ac91a065-5a2c-4f73-8011-5187151a6392 61 fields · synced Jun 20, 2026
EUDAMED 6ee03485-a4f3-4c41-bb3f-7c0777975b35 61 fields · synced Jun 20, 2026
EUDAMED 7808ed88-d7f7-4b88-aec3-c426bdfa4482 61 fields · synced Jul 9, 2026
EUDAMED 3bdf6340-050a-43f6-b273-41d35c6afd88 61 fields · synced Jul 9, 2026
EUDAMED 65c1b133-a128-435b-9a0d-c73770f99547 61 fields · synced Jul 9, 2026
EUDAMED 68b9bed6-3184-4652-88af-4e2f2f24bbeb 61 fields · synced Jul 9, 2026
EUDAMED 5c45da2d-ee02-4eed-a0b2-599828bca10e 61 fields · synced Jul 9, 2026
EUDAMED c31a47bc-001a-4c49-b488-836e8cf4feba 61 fields · synced Jul 9, 2026
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EUDAMED 0ebc2572-b1b7-4f82-bed0-d90271f18bd3 61 fields · synced Jul 9, 2026
EUDAMED 32c98b66-257d-43f0-accd-2b8aa3b8d08c 61 fields · synced Jul 11, 2026
EUDAMED 67a9c5c6-68c7-4c5b-84a8-141489966dfb 61 fields · synced Jul 11, 2026
EUDAMED 7b6da8ee-e9fa-421c-8213-f2ee5c4396ae 61 fields · synced Jul 12, 2026
EUDAMED a115ba61-28e8-4609-bebe-b7f1d1cfcce4 61 fields · synced Jul 12, 2026
EUDAMED 596ac250-ebcc-4cbe-9ebd-5ab2179d473d 61 fields · synced Jul 12, 2026
EUDAMED 7441a276-d066-421b-bef2-ce63f5cabd38 61 fields · synced Jul 14, 2026
EUDAMED e9d8114c-d031-48dd-b18e-f6aafa35f8f0 61 fields · synced Jul 14, 2026
EUDAMED 3258bd3b-16f5-45a1-9ef0-61eb2de5ccbc 61 fields · synced Jul 14, 2026
EUDAMED 36691b06-9c9a-4257-9734-9fbde50d3890 61 fields · synced Jul 18, 2026
EUDAMED dc3010a4-9cdb-4b28-b2b8-49b034b1617e 61 fields · synced Jul 18, 2026
EUDAMED 00743e2d-982a-4a7f-810e-b6042409d410 61 fields · synced Jul 18, 2026
EUDAMED 307489dd-469d-4c68-ba10-474515d97fb8 61 fields · synced Jul 18, 2026
EUDAMED 3797522b-6e60-4383-9c1a-82243d045cbf 61 fields · synced Jul 20, 2026
EUDAMED 8ef3262f-7e63-4d11-bc37-2a64459a4177 61 fields · synced Jul 21, 2026
EUDAMED 76250377-36ee-4dca-95d7-ad051107b4a4 61 fields · synced Jul 21, 2026
EUDAMED 5f5e6931-6cc1-4683-888f-d6b954dff311 61 fields · synced Jul 22, 2026
EUDAMED 7d4f8db0-ef12-461e-9989-2890bd9efb80 61 fields · synced Jul 24, 2026
EUDAMED 37d93807-5c0f-41bb-a632-d42fd8e02bd3 61 fields · synced Jul 30, 2026
EUDAMED afbb3c8f-033c-4d5f-acc5-7f0bac456089 61 fields · synced Jul 30, 2026
EUDAMED 68cdb597-1b55-4cca-b6fd-148e1189b313 61 fields · synced Jul 31, 2026
EUDAMED ca12a8dd-d1c8-452f-9f17-9f99bc53a7e8 61 fields · synced Aug 2, 2026
EUDAMED 5dc497bd-8474-4ab7-a51f-b92c0bcd6d62 61 fields · synced Aug 4, 2026
EUDAMED 49ce25fe-136e-4a3f-948e-51629577611f 61 fields · synced Sep 18, 2026
EUDAMED 44a18e8b-bad0-4cce-80bf-6e0fd3effcea 61 fields · synced Sep 18, 2026
EUDAMED 687e3d7b-cf48-4a09-8156-e167b199a3a0 61 fields · synced Oct 6, 2026