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MR-100 Resuscitator, Adult
EUDAMEDClass IIa (EU MDR)
Ref AR0001Model (L) ResuscitatorRef AR0010
Identity
- Trade Name
- MR-100 Resuscitator, Adult EUDAMED
- Device Name
- Reusable Resuscitator EUDAMED
- Model / Reference
- (L) Resuscitator EUDAMEDAR0001 EUDAMEDAR0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24710810085462 EUDAMED24710810087251 EUDAMED
- Basic UDI-DI
- 471081008RNLRAQ EUDAMED
- Direct Marketing DI
- 24710810085462 EUDAMED24710810087251 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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: Pulmonary resuscitator, manual, single-use
MR-100 Resuscitator, Adult by GaleMed Corporation — 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 | 471081008RNLRAQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED eb6bf8c3-ec85-4446-83bd-359758abf7a6 61 fields · synced Jul 14, 2026
- EUDAMED fca5f55a-7f4c-4588-972b-687f5c20305b 61 fields · synced Jul 14, 2026