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Surgical Positioning Pad
EUDAMEDClass I (EU MDR)
Ref SPPA81Model HL-A811series、HL-A812series、HL-A813series、HL-A814series、HL-A815series、HL-A816series、HL-A817series、HL-A818series、HL-A819seriesRef SPPA812Model HL-A8120series、HL-A8121series、HL-A8122series、HL-A8123series、HL-A8124series、HL-A8125series、HL-A8126series、HL-A8127seriesRef SPPA811Model HL-A8110series、HL-A8111series、HL-A8112series、HL-A8113series、HL-A8114series、HL-A8115series、HL-A8116series、HL-A8117series、HL-A8118series、HL-A8119series
Identity
- Trade Name
- Surgical Positioning Pad EUDAMED
- Device Name
- Surgical Positioning Pad EUDAMED
- Model / Reference
- HL-A811series、HL-A812series、HL-A813series、HL-A814series、HL-A815series、HL-A816series、HL-A817series、HL-A818series、HL-A819series EUDAMEDSPPA81 EUDAMEDHL-A8120series、HL-A8121series、HL-A8122series、HL-A8123series、HL-A8124series、HL-A8125series、HL-A8126series、HL-A8127series EUDAMEDSPPA812 EUDAMEDHL-A8110series、HL-A8111series、HL-A8112series、HL-A8113series、HL-A8114series、HL-A8115series、HL-A8116series、HL-A8117series、HL-A8118series、HL-A8119series EUDAMEDSPPA811 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975461368102 EUDAMED06975461368126 EUDAMED06975461368119 EUDAMED
- Basic UDI-DI
- 697546136SPPA81V3 EUDAMED697546136SPPA8123V EUDAMED697546136SPPA8113T EUDAMED
- Direct Marketing DI
- 06975461368102 EUDAMED06975461368126 EUDAMED06975461368119 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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: Device sterilization/disinfection container, reusable
Surgical Positioning Pad by Hi-Life Technology (hebei) Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697546136SPPA81V3 | Class I | Active |
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Manufacturer
- Manufacturer
- Hi-Life Technology (hebei) Co., Ltd
- EUDAMED SRN
- CN-MF-000023965
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 9ab1d58a-01d3-4347-ac90-4734e2dac35f 61 fields · synced Jul 12, 2026
- EUDAMED 6cf45655-e5cb-46f6-9922-fb6b13194917 61 fields · synced May 17, 2026
- EUDAMED b198780e-f6ca-4c45-9ed2-94bace664446 61 fields · synced May 17, 2026