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Manual Resuscitators
EUDAMEDClass I (EU MDR)
Ref T8131Ref T8211Ref T8121Ref T8241Ref T8221Ref T8141Ref T8341Ref T8311Ref T8111Ref T8331Ref T8321
Identity
- Trade Name
- Manual Resuscitators EUDAMED
- Device Name
- Manual Resuscitators EUDAMED
- Model / Reference
- T8131 EUDAMEDT8211 EUDAMEDT8121 EUDAMEDT8241 EUDAMEDT8221 EUDAMEDT8141 EUDAMEDT8341 EUDAMEDT8311 EUDAMEDT8111 EUDAMEDT8331 EUDAMEDT8321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970385728131 EUDAMED06970385728216 EUDAMED06970385728124 EUDAMED06970385728247 EUDAMED06970385728223 EUDAMED06970385728148 EUDAMED06970385728346 EUDAMED06970385728315 EUDAMED06970385728117 EUDAMED06970385728339 EUDAMED06970385728322 EUDAMED
- Basic UDI-DI
- 697038572MR1SS 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
Manual Resuscitators by Xiamen Tianzuo Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
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- 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 | 697038572MR1SS | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Tianzuo Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000018733
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (11)
- EUDAMED 2ef4ca5f-6dde-412d-a689-f717965cd8be 61 fields · synced Aug 1, 2026
- EUDAMED b9ea0da4-80c9-4845-b67f-50d5b390d86e 61 fields · synced May 16, 2026
- EUDAMED b9458958-7269-4d3a-9446-a8890db01396 61 fields · synced May 17, 2026
- EUDAMED d6dbbbfb-36d4-47c3-8285-fe96f9c5b70d 61 fields · synced May 17, 2026
- EUDAMED 5c7e76dd-ae7f-4194-90b0-fe2e8502b884 61 fields · synced May 17, 2026
- EUDAMED eaeb9ba1-3e78-4140-9df7-f6dc27b19171 61 fields · synced May 18, 2026
- EUDAMED 9a76f4c8-d144-4138-be65-d964a2ad29b2 61 fields · synced May 18, 2026
- EUDAMED fbdb697d-b37f-4e94-988a-dd16f9cf967a 61 fields · synced May 18, 2026
- EUDAMED 473758b4-1218-4b73-8e21-5c996326262b 61 fields · synced May 18, 2026
- EUDAMED c0182d33-f833-4dd8-960d-463654d033b9 61 fields · synced May 18, 2026
- EUDAMED 0fbfcc94-6c19-425e-8bd2-fdb681dd0fae 61 fields · synced May 19, 2026