R6 Resuscitator, Child w/Mask, #3
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- R6 Resuscitator, Child w/Mask, #3 EUDAMEDGaleMed FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, single-use FDA UDI
- Device Name
- Disposable Manual Resuscitator EUDAMEDRescu-6 Manual Resuscitator, Child w/ Mask #3 FDA UDI
- Model / Reference
- (L) Resuscitator EUDAMEDAR0029 EUDAMEDMG22 FDA UDI
- Description
- Rescu-6 Manual Resuscitator, Child w/ Mask #3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710810101779 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNL17U EUDAMED
- FDA Product Code
- BTM FDA UDI
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
- GMDN Term
- Pulmonary resuscitator, manual, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Pulmonary resuscitator, manual, single-use
R6 Resuscitator, Child w/Mask, #3 by GaleMed Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
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- Ventlab — Ventlab Corp. · Class I
- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471081008NNL17U | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 a82fdaad-e8d4-432d-9799-e9e47691c34b 61 fields · synced Jul 26, 2026
- FDA UDI 7d8a1ee4-e4f9-4468-974b-8812df171f52 34 fields · synced May 30, 2026