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Harness Pavlik Type
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 27112
by AliMed, LLC
Identity
- Trade Name
- HARNESS PAVLIK TYPE FDA UDI
- Generic Name
- Infant hip harness FDA UDI
- Device Name
- Lower Extremity Orthosis - Hip EUDAMED
- Model / Reference
- 27112 EUDAMED51968/NA/SM FDA UDI
Identifiers
- Catalog Number
- 2970002454 FDA UDI
- Primary DI / UDI-DI
- 00656204000225 EUDAMEDFDA UDI
- Basic UDI-DI
- 065620481MJ EUDAMED
- FDA Product Code
- IQZ FDA UDI
- EMDN Code
- Y061215 HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES) EUDAMED
- GMDN Term
- Infant hip harness FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infant hip harness
Harness Pavlik Type by AliMed, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Infant hip harness.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AliMed, LLC
Sources (2)
- FDA UDI 526a22fe-ed71-4bac-8af3-a3aca187333a 34 fields · synced Jul 16, 2026
- EUDAMED 057d7a6f-4c56-4eed-aeba-d0b4f96f7edb 61 fields · synced Jul 16, 2026