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Neonate Disposable Resuscitator
EUDAMEDClass IIa (EU MDR)
Ref XTA0008Ref XTA0007
Identity
- Trade Name
- Neonate Disposable Resuscitator EUDAMED
- Device Name
- Disposable Manual Resuscitator EUDAMED
- Model / Reference
- XTA0008 EUDAMEDXTA0007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980101151 EUDAMED06923980101144 EUDAMED
- Basic UDI-DI
- 69239801ND2PAPT EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Neonate Disposable Resuscitator by GaleMed (Xiamen) Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
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- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
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- 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 | 69239801ND2PAPT | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f0d98cd0-c4c0-47de-897f-0b164c2c667d 61 fields · synced Jul 21, 2026
- EUDAMED 2f530e0b-acbe-4343-8ff7-eef7d5281162 61 fields · synced May 17, 2026