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SteriHeel Baby
EUDAMEDClass IIa (EU MDR)
Ref 332235 SteriHeel Plus 1.14x2.8 Ref 331235 SteriHeel Plus 2.0x3.0 Ref 335235 SteriHeel Plus 0.65x1.4 Ref 333235 SteriHeel Plus 1.0x2.5Ref 334235 SteriHeel Plus 0.85x1.75
Identity
- Trade Name
- SteriHeel Baby EUDAMED
- Device Name
- Heel Incision EUDAMED
- Model / Reference
- 332235 SteriHeel Plus 1.14x2.8 EUDAMED331235 SteriHeel Plus 2.0x3.0 EUDAMED335235 SteriHeel Plus 0.65x1.4 EUDAMED333235 SteriHeel Plus 1.0x2.5 EUDAMED334235 SteriHeel Plus 0.85x1.75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945630135368 EUDAMED16945630135382 EUDAMED16945630135375 EUDAMED16945630135344 EUDAMED16945630135351 EUDAMED
- Basic UDI-DI
- 6945630130BG EUDAMED
- Unit of Use DI
- 06945630135385 EUDAMED06945630135347 EUDAMED06945630135354 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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: Blood lancet, single-use
SteriHeel Baby by Sterilance Medical (Suzhou) Inc. — Class IIa — 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 | 6945630130BG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- EUDAMED SRN
- CN-MF-000002860
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED e8d09faf-ad55-46e0-af00-1171d3cc22ef 61 fields · synced Aug 2, 2026
- EUDAMED 2782f538-6688-42c2-bc47-eaa7786748d4 61 fields · synced May 17, 2026
- EUDAMED 62a99838-111f-471e-9b22-2b65f01da0ab 61 fields · synced May 18, 2026
- EUDAMED 45ae8bf0-007f-4697-ad62-1d86489e15cd 61 fields · synced May 18, 2026
- EUDAMED 28d5af53-f82d-4e93-9a2a-b26d6d9ee711 61 fields · synced May 19, 2026