Identity
- Trade Name
- PocketCPR HeartPush EUDAMED
- Device Name
- PocketCPR HeartPush EUDAMED
- Model / Reference
- CPR-HTP-MW001 EUDAMEDHTSV-IFU-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806411123459 EUDAMED
- Basic UDI-DI
- 8801339HTPMW001AJ EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class I 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
PocketCPR HeartPush by HEART SAVER Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (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 | 8801339HTPMW001AJ | Class I | Active |
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Manufacturer
- Manufacturer
- HEART SAVER Inc.
- EUDAMED SRN
- KR-MF-000050696
- Authorised Representative
- Freyr Regulatory GmbH DE-AR-000047121
Sources (1)
- EUDAMED 668f8ebc-13b2-47aa-b85d-da85c0956fe8 61 fields · synced Jun 18, 2026